Clinical Update for November 2017

Drug Reviewed Trulance (plecanatide)

FDA approval date

1/19/17

Indications

Chronic idiopathic constipation (CIC)

Review Summary

 

Advantages

  • First FDA approved uroguanylin analog approved for CIC
  • Lower side-effect profile compared to linaclotide (Linzesss®) and lubiprostone (Amitiza®)
  • No known drug interactions
  • No dosage adjustments needed in renal or hepatic insufficiency due to low systemic availability

Disadvantages

  • High cost
  • No head-to-head trials with linaclotide or lubiprostone
  • Only indicated for CIC, no data available for use in irritable bowel syndrome with constipation (IBS-C) or in opioid-induced constipation
  • Long-term data unavailable.  Treatment with plecanatide was studied for only 12 weeks as compared to linaclotide long-term data

Recommendation(s)

Do not add Trulance to the Ventegra commercial formularies.  In appropriate patients, the preferred commercial formulary alternative is Linzess®

 

Drug Reviewed Safinamide (Xadago®)

FDA approval date

3/21/17

Indications

Adjunct treatment for patients with Parkinson’s during the “off-phase” of treatment with levodopa/carbidopa

Review Summary

 

Advantages

  • Once daily oral medication vs. conventional selegiline dosed twice daily
  • Possible added benefit from safinamide’s non-dopaminergic mechanism of action demonstrated in vitro
  • Well-tolerated and similar to placebo in adverse events in pivotal clinical trials

 

Disadvantages

  • Compared in general to other MAO-B inhibitors, safinamide showed no major increase in on time
  • Greater cost compared to similar medications in its class
  • Increased dyskinesia as a treatment emergent adverse event reported in the SETTLE study, study 016 and study 018 (14.6%), which resembles rates reported with rasagiline (18%) in patients with fluctuating Parkinson’s
  • Use not addressed in current guidelines in the treatment of Parkinson’s disease
  • Use in combination therapy only.  Rasagiline may be used monotherapy

Recommendation(s)

Do not add safinamide (Xadago®) to the Ventegra commercial formularies. 

Drug Reviewed  Dupilumab (Dupixent®)

FDA approval date

3/28/17

Indications

Atopic dermatitis (AD), moderate to severe, not adequately controlled with topical therapies or when those therapies are not warranted

Review Summary

 

 

  • First biologic and first injectable agent approved to treat AD
  • Available efficacy and safety data supports dupilumab as safe and effective in short-term clinical trials for AD
  • CHRONOS study showed increased efficacy when combined with topical corticosteroids in severe AD
  • No long-term safety or efficacy trials have been completed to date
  • No trials evaluating dupilumab directly to the standard of care treatments (topical corticosteroids) for AD
  • $37,000 Annual wholesale acquisition (WAC) cost may outweigh the benefit for some patients

Recommendation(s)

Do not add to Ventegra commercial formularies.  Maintain Dupilumab as a non-preferred specialty drug subject to prior approval criteria

 

Drug Reviewed  Crisaborole (Eucrisa)

FDA approval date

12/14/16

Indications

Topical treatment of mild to moderate Atopic dermatitis (AD) in patients 2 years of age and older.

Review Summary

 

 

  • New topical PDE-4 inhibitor that offers a new treatment option for patients with AD that have not achieved a successful response on traditional therapies 
  • Appears safe and effective for the treatment of AD in short-term trials
  • No trials comparing crisaborole directly to the currently accepted standards of care for the treatment of AD
  • Long-term effectiveness beyond 52 weeks is not certain.  Majority of efficacy data provided for only 29 days on efficacy and 253 days for safety

Recommendation(s)

Do not add to Ventegra commercial formularies. Prior authorization required.

 

Drug Reviewed  Ocrelizumab (Ocrevus)

FDA approval date

3/28/17

Indications

Treatment of relapsing-remitting multiple sclerosis (RRMS) or primary progressive multiple sclerosis (PPMS) in adult patients

Review Summary

 

Advantages

  • First and only FDA approved medication for PPMS
  • Superior to interferon beta-1a (Rebif) by reducing annualized relapse rate (ARR) almost 50% over two years
  • Infused every 6 months (twice yearly)
  • Competitively priced

Disadvantages

  • Infusion that must be administered by a health care professional
  • Patient must be pre-medicated to help mitigate infusion reactions
  • Higher incidence of infusion reaction, infection, and possible malignancy compared to interferon beta-1a and therefore more long-term safety data is needed

Recommendation(s)

Maintain ocrelizumab (Ocrevus) as a medical benefit in the non-preferred specialty category subject to prior approval.