Drug coverage policies

Below are links to our policies relating to drug coverage, including limitations, criteria for coverage, and treatment guidelines.

Botulinum toxin

Coverage decision

Botulinum toxin products require prior authorization. Authorization criteria and coverage limitations depend on the condition being treated. You can request authorization by completing and submitting the prior authorization form for chronic migraine or for non-migraine indications.

OnabotulinumtoxinA for prevention of chronic migraine (up to five treatment courses)

Coverage criteria

Initial treatment course (all of the following conditions must be met):

  1. Patient meets the International Headache Society’s diagnostic criteria for chronic migraine (headache on at least 15 days per month for more than three months, which has the features of migraine headache on at least 8 days per month).
  2. Patient has kept a daily headache diary for at least three months to confirm diagnosis and establish baseline.
  3. Chronic migraine diagnosis is causally related to an accepted industrial injury or occupational disease.
  4. Patient has tried and failed at least three prophylaxis drugs from at least two different drug classes.
  5. Migraine condition is being appropriately managed to avoid medication overuse (rebound) headaches.
  6. Patient is at least 18 years old.

Additional treatment courses (all of the following conditions must be met):

  1. Patient’s daily headache diary demonstrates a greater than 50% reduction in headache frequency after two treatment cycles.
  2. Patient has not already met the five-treatment course limit.
Background information

The state’s Health Technology Clinical Committee (HTCC) reviewed the treatment of chronic migraine and chronic tension-type headache in May 2017 and finalized the coverage determination on July 14, 2017. HTCC then revised the determination on July 13, 2018 to remove the following requirement for discontinuation, “Has changed to episodic migraine (defined as < 15 headache days per month).” Complete information is available at: http://www.hca.wa.gov/about-hca/health-technology-assessment/health-technology-reviews.

Effective date of initial coverage decision is 12/1/17. Decision was revised on 10/1/18, which is retroactive to 12/1/17.

Regulatory authority and related information

RCW 51.08.100
RCW 51.08.140
RCW 70.14.080 through 70.14.130
Health Technology Assessment Program


Botulinum toxin for non-migraine indications (up to two treatment courses, except for catastrophic injuries*)

Coverage criteria

Initial treatment course (all of the following conditions must be met):

  1. Condition being treated is causally related to the industrial injury or occupational disease.
  2. Condition being treated is an FDA-approved indication for the requested botulinum toxin product, with the exception of cervicobrachial syndrome, for which a botulinumtoxinA formulation (abobotulinumtoxinA – Dysport®, incobotulinumtoxinA – Xeomin®, or OnabotulinumtoxinA – Botox®) may be covered (see Appendix A of Neurogenic Thoracic Outlet Syndrome Treatment Guideline).
  3. Patient has tried and failed conservative treatment, such as oral medication and physical therapy.
  4. Botulinum toxin injections are part of an agreed upon treatment plan with clearly stated treatment goals of completing vocational rehabilitation and/or returning to work.

Additional treatment courses (all of the following conditions must be met):

  1. Patient did not experience a severe adverse outcome from a previous botulinum toxin treatment course.
  2. Previous treatment course resulted in the patient being able to engage in vocational rehabilitation or return to work.
  3. Patient has not already met the two-treatment course limit.

*Patients with catastrophic injuries, such as spinal cord injury in which significant recovery of physical function is not expected, are exempt from the two-course limit and the requirement of meaningful improvement in function. A maximum of four courses of injections may be authorized per year, with prior authorization.

Buprenorphine and or buprenorphine/naloxone transmucosal

Coverage decision

Buprenorphine and buprenorphine/naloxone transmucosal products require prior authorization. We may cover it for a limited time under the following circumstances, but not for pain management or other off-label uses.

For opioid wean

You must provide documentation of a time-limited opioid taper plan

Authorization is limited to 30 days. Upon your request, an additional 30 days is available if you have documented progress on the opioid wean.

For opioid use disorder

You must:

  • Document that your patient has failed steps 1 and 2 taper (see WAC 296-20-03030);
  • Document that your patient is diagnosed with opioid use disorder by DSM V criteria and this condition is identified as a barrier to recovery; and,
  • Submit a time-limited plan documenting how temporary treatment of this condition will allow significantly improved work capacity and/or the ability to progress in vocational retraining.

Payment for treatment of opioid use disorder is limited to six months per claimant.

Buprenorphine transdermal

Coverage decision

Buprenorphine transdermal is not routinely covered. On an exception basis, we may cover it when a patient:

  1. Requires continuous opioid combination that cannot be managed by lesser means, such as non-steroidal analgesics, opioid combination products, or immediate-release opioids;
  2. Has tried and failed two (2) preferred opioids; AND
  3. Was previously maintained on ≤ 80mg/d of morphine equivalent dose (MED) with current daily opioid dose tapered to ≤ 30mg/d MED before starting buprenorphine transdermal.

We have reviewed the literature and safety profile of buprenorphine transdermal system. The pharmacokinetics of transdermal buprenorphine demonstrate systemic availability that is equivalent to injectable routes. See WAC 296-20-03014 (2).

Coverage Decision

CGRP antagonists for migraine prophylaxis require prior authorization for coverage.

Criteria for initial 90-day trial:

  1. Diagnosis of chronic migraine, defined as headache on ≥ 15 days per month for > 3 months, which has the features of migraine headache on ≥ 8 days per month.
  2. Migraine diagnosis is causally related to an accepted industrial injury or occupational disease.
  3. The patient has kept a daily headache diary for at least 3 months prior to confirm diagnosis and establish baseline frequency, duration and quality of headaches.
  4. The patient has been screened for medication overuse headache, defined by the use of triptans for 10 or more days per month and/or the use of analgesics for 15 or more days per month. If present, discontinuation of the suspected medication(s) is recommended for 2 months.
  5. The patient has tried and failed at least 3 preferred prophylaxis drugs from at least 2 different classes (unless contraindicated):
    1. Anticonvulsants: divalproex sodium/valproate, topiramate
    2. Beta-blockers: metoprolol, propranolol, timolol
    3. Antidepressants: amitriptyline, venlafaxine
  6. The patient has not received botulinumtoxinA (Botox) injections for migraine prophylaxis in the previous 12 weeks, and will not receive it or other CGRP antagonists concurrently with approval.
  7. There are no contraindications to the use of CGRP antagonists: history of adverse reactions or hypersensitivity to the medication or any component thereof.
  8. CGRP antagonists are part of an agreed upon, time-limited, rehabilitative treatment plan with clearly stated treatment goals (e.g., participation in vocational rehabilitation and/or return to work).

Criteria for continued coverage:

  1. No serious adverse events experienced from treatment with CGRP antagonists.
  2. Migraine days per month are reduced by at least 50% from baseline.
  3. Use of the CGRP antagonist resulted in documented rehabilitative benefit.

References:

  1. Cutrer, FM. Pathophysiology, clinical manifestations, and diagnosis of migraine in adults. UpToDate. https://www.uptodate.com (accessed on Dec 06, 2019).
  2. Henson B, Hollingsworth H, Nevois E, Herndon C. Calcitonin Gene-Related Peptide (CGRP) Antagonists and Their Use in Migraines. J Pain Palliat Care Pharmacother. 2019;Nov 25:1-10. 
  3. Silberstein SD, Holland S, Freitag F, Dodick DW, Argoff C, Ashman E. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012;78:1337-45.
  4. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016;86(19):1818-26.
  5. Steiner TJ, Jensen R, Katsarava Z, et al. Aids to management of headache disorders in primary care (2nd edition). J Headache Pain. 2019;20,57.
  6. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211. 

Carisoprodol

Coverage decision

Carisoprodol products, including combinations with aspirin and codeine, are not covered. See the Drug Lookup for safer alternatives.

List of carisoprodol products:

  • Carisoprodol (Soma®)
  • Carisoprodol with aspirin (Soma Compound®)
  • Carisoprodol with aspirin and codeine (Soma Compound with Codeine®)

Carisoprodol is metabolized by the liver and broken down into meprobamate. Meprobamate is an anxiolytic and a federally controlled substance subject to physical dependence. After an evidence-based review, the Washington State Pharmacy and Therapeutics Committee has recommended the removal of carisoprodol products from Labor & Industries formulary for safety reasons.

Compounded drug products

Coverage decision

Compounded drug products require prior authorization except for compounded multiple ingredient topical preparations, which are not covered. If you do not get authorization before compounding, you may not be paid.

Examples of non-covered compounded topical preparations:

  • Diclofenac + baclofen + cyclobenzaprine + tetracaine preparation
  • Ketamine + cyclobenzaprine + diclofenac + gabapentin + orphenadrine + tetracaine preparation
  • Ibuprofen + ketoprofen + cyclobenzaprine preparation
  • Ketoprofen + ketamine + gabapentin + lidocaine preparation

There are many available alternatives, such as oral generic nonsteroidal anti-inflammatory drugs, muscle relaxants, tricyclic antidepressants, gabapentin and topical salicylate and capsaicin creams on the Outpatient Drug Formulary.

Compounded drug products include, but are not limited to, antibiotics for intravenous therapy, pain cocktails for weaning, total parenteral nutrition and non-commercially available preparations.

Direct-acting antivirals for hepatitis C

Coverage Decision

Direct-acting antivirals for hepatitis C require prior authorization (F252-112-000) for coverage. Coverage criteria include, but are not limited to:

  • Hepatitis C is an accepted condition
  • Patient has evidence of active chronic hepatitis C infection
  • Drug is prescribed consistent with FDA labeling

Preferred agents in this drug class:

  • Glecaprevir/pibrentasvir (Mavyret®).
  • Sofosbuvir/velpatasvir (Epclusa®) – for decompensated cirrhosis.
  • Sofosbuvir/velpatasvir/voxilaprevir (Vosevi®) – for patients who have failed previous antiviral treatment (see FDA labeling).

Drug therapy for acute treatment of migraine headache

Coverage Decision

Analgesics, such as acetaminophen and NSAIDs, should be considered drugs of choice for acute treatment of mild to moderate migraine headaches without vomiting or severe nausea.

Triptans, calcitonin gene-related peptide (CGRP) antagonists and ditans require prior authorization for the acute treatment of migraine headaches that are causally related to an industrial injury or occupational disease:

  • Triptans
    Triptans have an established record of safety and efficacy and are considered first-line agents. Generic triptans are coverable upon request.
  • CGRP Antagonists
    Due to a lack of long-term safety and efficacy data and comparative evidence versus triptans, rimegepant and ubrogepant are considered second-line agents. The coverage of CGRP antagonists requires previous trials of at least two triptans, unless the patient has a contraindication to their use.
  • Ditans
    Lasmiditan lacks long-term safety and efficacy data and comparative evidence versus triptans. In addition, lasmiditan is associated with central nervous system side effects, such as drowsiness and dizziness, and is a controlled substance. As such, ditans are considered third-line agents and require previous trials of at least two triptans and at least one CGRP antagonist, unless trials are contraindicated.

Prescribing of drug therapy for acute treatment of migraine headaches should be consistent with FDA-recommended dosing guidelines and contraindications to use and should account for other patient-specific factors.

References:

  1. American Headache Society. The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. Headache 2019; 59:1-18.
  2. Crop R, Goadsby PJ, Stock DA, et al. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomized, phase 3, double-blind, placebo-controlled trial. Lancet 2019; 394:737-45.
  3. Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the Treatment of Migraine. N Engl J Med 2019; 381:2230-41.
  4. Goadsby PJ, Wietecha LA, Dennehy EB, et al. Phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for acute treatment of migraine. Brain 2019; 142:1894-1904.
  5. Institute for Clinical and Economic Review (ICER). Acute Treatments for Migraine: Final Policy Recommendations. February 25, 2020.
  6. Kuca B, Silberstein SD, Wietecha L, et al. Lasmiditan is an effective acute treatment for migraine: A phase 3 randomized study. Neurology 2018; 91:e2222-32.
  7. Lipton RB, Croop R, Stock EG, et al. Rimegepant, an Oral Calcitonin Gene-Related Peptide Receptor Antagonist, for Migraine. N Engl J Med 2019; 381:142-9.
  8. Lipton RB, Dodick DW, Ailani J, et al. Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine: The ACHIEVE II Randomized Clinical Trial. JAMA 2019; 322:1887-98.
  9. Oswald JC, Schuster NM. Lasmiditan for the treatment of acute migraine: a review and potential role in clinical practice. J Pain Res 2018; 11:2221-7.
  10. https://www.uptodate.com/contents/acute-treatment-of-migraine-in-adults (Accessed on May 15, 2020).

Drug therapy for neuropathic pain

Coverage Decision

Tricyclic antidepressants, duloxetine, and gabapentin are covered for neuropathic pain (see definition below) when associated with a work-related condition or occupational disease. Pregabalin requires prior authorization. Unless it is prescribed for an FDA-approved indication, pregabalin can be covered for claim-related neuropathic pain only if the above formulary drugs have been tried and failed.

Certain formulations of capsaicin, menthol, and lidocaine are covered for localized neuropathic pain or when used as adjunctive therapy (check coverage status of specific products using our drug lookup tool).

Opioids do not have good quality evidence to support their use in the treatment of neuropathic pain. Coverage of opioids is subject to department guidelines and rules.

The treatment of trigeminal neuralgia is considered separately, as evidence supports use of carbamazepine and oxcarbazepine for this specific indication.

Prescribing of drug therapy to treat neuropathic pain should be consistent with FDA-recommended dosing guidelines and contraindications to use and should account for other patient-specific factors.

Neuropathic pain is pain that arises as a direct consequence of a lesion or disease affecting the somatosensory nervous system. Neuropathic pain is described as lancinating, paroxysmal, burning, constant, cramping; and evoked dysesthesia, allodynia, hyperalgia, or hyperpathia. Examples of neuropathic pain conditions or diseases that are known to cause neuropathy includes, but not limited to, spinal cord injury, cauda equina syndrome, phantom limb pain and traumatic nerve injury.

This coverage decision is based on a review of literature and evidence-based guidelines developed by: the International Association for the Study of Pain (IASP), Neuropathic Pain Special Interest Group, European Federation of Neurological Societies, Canadian Pain Society, and a collaboration between the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation.

Abbreviated list of literature reviewed, including current pain guidelines
  1. Attal N, Cruccu G, Baron R, et al. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol. 2010;17:1113-23.
  2. Bril V, England J, Franklin GM, et al. Evidence-based guideline: treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2011;76:1758-65.
  3. Derry S, Moore RA. Topical lidocaine for neuropathic pain in adults. Cochrane Database Syst Rev 2014;CD010958.
  4. Enke O, New HA, New CH, et al. Anticonvulsants in the treatment of low back pain and lumbar radicular pain: a systematic review and meta-analysis. CMAJ. 2018;190:E786-93.
  5. Finnerup NB, Attal N, Haroutounian S, et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015;14(2):162-73.
  6. Mathieson S, Maher CG, McLachlan AJ, et al. Trial of pregabalin for acute and chronic sciatica. N Eng J Med 2017;376:1111-20.
  7. McNicol ED, Midbari A, Eisenberg E. Opioids for neuropathic pain. Cochrane Database Syst Rev 2013;CD006146.
  8. Moulin DE, Boulanger A, Clark AJ, et al. Pharmacological management of chronic neuropathic pain: revised consensus statement from the Canadian Pain Society. Pain Res Manag. 2014;19(6):328-35.
  9. Neuropathic pain in adults: pharmacological management in non-specialist settings. NICE guideline (CG173). London (UK): National Institute for Health and Care Excellence; 2017. Available: www.nice.org.uk/guidance/cg173 (accessed on July 18, 2018).
  10. https://www.uptodate.com/contents/overview-of-the-treatment-of-chronic-non-cancer-pain (accessed on July 18, 2018).

Fentanyl transdermal

Coverage decision

Fentanyl transdermal products are not routinely covered. On an exception basis, we may cover it when a patient:

  1. Demonstrated opioid tolerance AND,
  2. Requires continuous opioid analgesia that cannot be managed by lesser means, such as non-steroidal analgesics, opioid combination products, or immediate-release opioids AND,
  3. Cannot tolerate other long-acting opioids OR,
  4. Has a medical contraindication to the use of oral opioids (e.g., the patient cannot swallow or the patient has dementia and cannot manage their own daily medications).

Opioid tolerance is defined as taking opioids, for a week or longer, at least:

  • Morphine 60mg/day,
  • Oxycodone 30mg/day,
  • Hydromorphone 8mg/day or
  • An equianalgesic dose of another opioid.

We have reviewed the literature and safety profile of fentanyl transdermal. While the drug is absorbed relatively slowly, it reaches peak levels equivalent to intravenous use and is metabolized and excreted slowly. The pharmacokinetics of fentanyl transdermal demonstrates systemic availability that is equivalent to injectable routes. See WAC 296-20-03014(2).

Lidocaine infusion for chronic pain

Coverage Decision

Intravenous infusion of lidocaine for chronic pain is considered investigational and is not covered except under the provisions of WAC 296-20-02850 (When may the department cover controversial, obsolete, investigational or experimental treatment?).

There is insufficient high quality evidence to demonstrate that intravenous infusion of lidocaine is safe and effective for managing chronic pain or that its use for this indication is curative/rehabilitative. Supportive evidence is limited, primarily, to short-term pain improvement in selected neuropathic pain conditions.

References: 

  1. Challapalli V, Tremont-Lukats IW, McNicol ED, Lau J, Carr DB. Systemic administration of local anesthetic agents to relieve neuropathic pain. Cochrane Database Syst Rev. 2019 Oct 7;2019(10).
  2. Iacob E, Hagn EE, Sindt J, Brogan S, Tadler SC, Kennington KS, Hare BD, Bokat CE, Donaldson GW, Okifuji A, Junkins SR. Tertiary Care Clinical Experience with Intravenous Lidocaine Infusions for the Treatment of Chronic Pain. Pain Med. 2018 Jun 1;19(6):1245-1253.
  3. Kim YC, Castañeda AM, Lee CS, Jin HS, Park KS, Moon JY. Efficacy and Safety of Lidocaine Infusion Treatment for Neuropathic Pain: A Randomized, Double-Blind, and Placebo-Controlled Study. Reg Anesth Pain Med. 2018 May;43(4):415-424.
  4. Mayhew A, Argaez C. Intravenous lidocaine for chronic pain: a review of the clinical effectiveness and guidelines. Ottawa: CADTH; 2018 Jan (CADTH rapid response report: summary with critical appraisal).
  5. Moulin DE, Morley-Forster PK, Pirani Z, Rohfritsch C, Stitt L. Intravenous lidocaine in the management of chronic peripheral neuropathic pain: a randomized-controlled trial. Can J Anaesth. 2019 Jul;66(7):820-827.
  6. Tan X, Ma L, Yuan J, Zhang D, Wang J, Zhou W, Cao S. Intravenous infusion of lidocaine enhances the efficacy of conventional treatment of postherpetic neuralgia. J Pain Res. 2019 Aug 20;12:2537-2545.
  7. Tremont-Lukats IW, Hutson PR, Backonja MM. A randomized, double-masked, placebo-controlled pilot trial of extended IV lidocaine infusion for relief of ongoing neuropathic pain. Clin J Pain. 2006 Mar-Apr;22(3):266-71.
  8. Van den Heuvel SAS, et al.Intravenous Lidocaine: Old-School Drug, New Purpose-Reduction of Intractable Pain in Patients with Chemotherapy Induced Peripheral Neuropathy. Pain Res Manag. 2017.
  9. Wilderman I, Pugacheva O, Perelman VS, Wansbrough MCT, Voznyak Y, Zolnierczyk L. Repeated Intravenous Lidocaine Infusions for Patients with Fibromyalgia: Higher Doses of Lidocaine Have a Stronger and Longer-Lasting Effect on Pain Reduction. Pain Med. 2019 Oct 16:pnz251. 
  10. Yousefshahi F, Predescu O, Francisco Asenjo J. The Efficacy of Systemic Lidocaine in the Management of Chronic Pain: A Literature Review. Anesth Pain Med. 2017 Apr 22;7(3):e44732.

Medical foods

Coverage Decision

Medical foods and their convenience packs (“co-packs”) are not covered. There is a lack of good quality scientific evidence of efficacy for the intended disease or condition. Co-packs are unapproved drugs unless the FDA specifically approves them.

Examples of medical food products:

  • Deplin® (L-methylfolate)
  • Theramine® (arginine, glutamine, 5-hydroxytryptophan and choline)
  • Gabadone® (5-hydroxytryptophan, gamma aminobutyric acid and choline)

Examples of convenience packs (co-packs):

  • Theraproxen® (Theramine and naproxen)
  • Gaboxetine® (Gabadone and fluoxetine)

Medical food products contain nutritional supplements for the dietary management of diseases or conditions. These products are required to comply with provisions of medical foods and food manufacturing. However, they are not approved or registered with the FDA.

Opioid transmucosal products

Coverage decision

Opioid transmucosal products (see the list below) are not routinely covered. On an exception basis, it may be covered when a patient:

  1. Has an accepted cancer claim AND,
  2. Requires treatment for moderate-to-severe breakthrough cancer pain AND,
  3. Demonstrated opioid tolerance.

Opioid tolerance is defined as taking opioids, for a week or longer, at least:

    • Morphine 60mg/day,
    • Oxycodone 30mg/day,
    • Hydromorphone 8mg/day or
    • An equianalgesic dose of another opioid.

List of opioid transmucosal products:

  • Fentanyl buccal tablet/soluble film (Fentora/Onsolis)
  • Fentanyl nasal spray (Lazanda)
  • Fentanyl sublingual tablet/spray (Abstral/Subsys)
  • Fentanyl transmucosal lozenge (Actiq)
  • Sufentanil sublingual tablet (Dsuvia)

We have reviewed the literature and safety profile of opioid transmucosal products. The pharmacokinetics of opioid transmucosal products demonstrate systemic availability that are equivalent to injectable routes. See WAC 296-20-03014(2).

Phosphodiesterase-5 (PDE5) inhibitors quantity limit for erectile dysfunction

Coverage decision

Effective 7/1/2022

When prescribed to treat accepted erectile dysfunction, coverage of PDE5 inhibitors is limited to generic formulations at a maximum of 8 tablets per 30-day supply, except for formulations which have FDA-approved indication for daily dosing.

Limited to maximum of 8 tablets per 30 days:

  • Sildenafil – all strengths
  • Tadalafil – 10 & 20mg tablets
  • Vardenafil – all strengths

Limited to maximum of 30 tablets per 30 days:

  • Tadalafil – 2.5 & 5mg tablets

Tramadol

Coverage decision

Tramadol is an opioid and coverage is subject to our opioid rules and guidelines. See WAC 296-20-03030 through WAC 296-20-03085 for rules on opioid prescribing.

Tramadol is a centrally acting analgesic drug. Its pharmacologic effect is due to the binding of both parent and metabolite, M1, to mu opioid receptors as well as inhibiting the reuptake of norepinephrine and serotonin.

The American Hospital Formulary Service (AHFS) Pharmacologic-Therapeutic Classification recognizes tramadol as an opiate agonist. This determination is made regardless of the risk level for potential abuse or whether it has "pure" opiate agonist properties.