NCRx Pipeline Report 1.1.20

Erica Guetzlaff  •   January 1, 2020

National CooperativeRx constantly monitors the pharmaceutical pipeline. As treatment options change, it’s important to know which drugs bring the highest value. Our quarterly NCRx Pipeline Reports provide insight from our clinical team on what changes you can expect to see on the market and how they impact plan performance.

Vumerity™ (diroximel fumarate):  This medication is used to treat multiple sclerosis (MS), including clinically-isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. It was approved based on clinical data from Tecfidera®, an existing MS drug with a very similar mechanism of action. While both drugs are made by Biogen, Vumerity’sTM claim to fame is its improved gastrointestinal tolerability over Tecfidera®. Vumerity’sTM approval comes at a perfect time for Biogen, as two generic companies have filed challenges to Tecfidera’s® patent and the US Food and Drug Administration (FDA) has granted tentative approval of several generic equivalents which could launch as soon as June 2020. In conclusion, although VumerityTM is priced slightly lower than Tecfidera®, the cost savings with generic Tecfidera® are likely to result in a lower cost than VumerityTM.

Anticipated Launch: Quarter one of 2020.

Impact: Low. Will likely see more people switch to VumerityTM from Tecfidera® compared to new users. It is yet unclear how CVS will handle this product. MS affects about 1 million Americans.

Price: The wholesale acquisition cost is $88,000 annually. Given the wide variety of options in the MS class and the potential to see generics for Tecfidera® soon, this list price has been widely criticized.

Exenatide implant (ITCA 650):  This drug will be used to treat type II diabetes, along with diet and exercise. Exenatide is the same active ingredient found in Byetta® and Bydureon® and is part of a drug class known as glucagon-like peptide-1’s (GLP-1’s). If approved, ITCA 650 would be the first implantable GLP-1 on the market, joining several injectable products and one oral formulation. The matchstick-sized implant is placed in the abdomen for up to six months and releases drug osmotically at a pre-determined rate. This mode of administration may be helpful to patients who struggle with adherence to the oral or injectable products. One study, not specific to diabetes, showed a 10% increase in adherence was associated with a 1.2% reduction in hospitalization and emergency room visits.1  The drug appears to work as well as others in its class, if not better, due to its potential to provide perfect adherence for users. The drug is not without drawbacks, however. The rate of discontinuation due to side effects was 8.5% for ITCA 650compared to about 5% for Bydureon®3, and the need for a minor surgical procedure to insert the device may be a turn-off for some patients.

Anticipated Launch: Quarter one of 2020 (FDA decision expected March 2020).

Impact: Given the potential for this drug to be covered through medical instead of pharmacy insurance, the impact may be high.

Price: Currently unknown, yet device cost is likely to be comparable to its injectable and oral counterparts. However, the costs of device insertion and early discontinuation of treatment must be considered, as those factors could contribute significantly to overall treatment cost.

Entyvio® (vedolizumab) subcutaneous:  Entyvio® is used to treat moderate to severe ulcerative colitis. This drug is currently only available as an intravenous infusion; approval of a subcutaneous formulation would enable patients to self-administer the treatment after receiving the loading doses in the clinic through an IV. Subcutaneous maintenance doses would be injected every two weeks, while conventional dosing with the intravenous product requires infusions every eight weeks. Entyvio® subcutaneous appears to work just as well as the intravenous product. In a study against placebo, remission was achieved in 46.2% of patients taking Entyvio® subcutaneously, 46.2% of patients taking Entyvio® intravenously and 14.3% of patients taking a placebo.4 Additionally, a recent study showed superiority of Entyvio® (intravenous) over Humira®, a common first-line biologic for ulcerative colitis.5 Availability of a self-administered product creates a larger potential to shift costs from medical insurance to prescription insurance, which can be a benefit or a drawback depending on plan design and the pricing of the subcutaneous product.

Anticipated Launch: Quarter one of 2020.

Impact: Moderate. Ulcerative colitis affects about 907,000 Americans.6 If subcutaneous Entyvio is eventually approved for Crohn’s disease (as with the intravenous formulation), the impact may be higher.

Price: Currently unknown. The cost of the IV formulation is $6,500 every eight weeks. For reference, Humira® is priced at $5,200 per four-week supply.

Bempedoic acid and bempedoic acid/ezetimibe:  For lowering LDL (“bad”) cholesterol in patients already taking maximally tolerated statin therapy. Bempedoic acid works differently than any other LDL-lowering drug on the market by inhibiting ATP citrate lyase and preventing cholesterol synthesis. It will also be available in combination with ezetimibe (generic of Zetia®). It has been shown to reduce LDL by 18% when added onto statin therapy and by 21-29% by itself.7 The drug also appears to have a small positive effect on hemoglobin A1C levels (a measure of blood sugar control). Perhaps the most marketable attribute of this drug is that is does not appear to cause muscle symptoms that are common with statin drugs. Data around the drug’s ability to reduce the risk of cardiovascular events (like heart attack and stroke) is expected in 2022, but its solid ability to reduce LDL will likely be enough to build clinicians’ confidence in the drug. This will likely be a preferred treatment for patients who are already taking a statin and/or other lipid-lowering medications and have not reached their LDL goal, and in those who cannot tolerate statin therapy because of muscle symptoms. The drug’s most notable safety risk is its association with acute gout (inflammatory arthritis) attacks in patients with history of or risk factors for gout.

Anticipated Launch: Quarter one of 2020 (FDA decision expected February 2020).

Impact: This will depend on where the drug is placed within the cholesterol treatment guidelines, but there is potential for high impact given the unique mechanism of action and low risk of muscle symptoms. 5-20% of patients are unable to tolerate statin medications because of muscle symptoms, and 34% of patients taking statins are unable to achieve their LDL goal.8 39.2 million Americans were taking statin medications in 2013.9

Price: It is expected to cost $9-10 per day. For reference, most statins cost less than $20 for a month’s supply, and the newer PCSK-9 drugs cost around $1,200 per month.

Recently Approved:

Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor):  For cystic fibrosis (CF) in patients ages 12 or older with at least one F508del mutation in the CFTR gene. For most patients (patients with two F508del mutations), this therapy will replace another CF therapy, like Orkambi. However, Trikafta does represent a new therapy option for 6,000 patients in the US who cannot use Orkambi because they have a unique set of mutations causing their CF disease.

 

  1. Jha AK, Aubert RE, Yao J, Teagarden JR, Epstein RS. Greater adherence to diabetes drugs is linked to less hospital use and could save nearly $5 billion annually. Health Affairs. 2012;31(8):1836-1846.
  2. Baron M, Azeem R, Buse J, Kjems L, Rosenstock J. A randomised, double-blind, placebo-controlled, 39 week trial of ITCA 650 as add-on therapy in type 2 diabetes (112, Webcast). Oral presentation at: the 51st Meeting of the European Association for Diabetes Study; September 14-18, 2015; Stockholm, Sweden.
  3. Amylin Pharmaceuticals. US Pharmacist Product Information Guide:  Bydureon Once-Weekly.  June 2012.
  4. Sandborn WJ, et al. LB03. Visible-1. Presented at: UEG Week Vienna 2018; Oct. 20-24, 2018.
  5. Sands BE, Peyrin-Biroulet L, Loftus EV. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. N Engl J Med 2019; 381:1215-1226.
  6. Crohn’s and colitis foundation of America. The facts about inflammatory bowel diseases 2014; page 10.
  7. Honigberg MC, Natarajan P. Bempedoic acid for lowering LDL cholesterol.  JAMA November 12, 2019; 322(18): 1769-71.
  8. Schleyer T, Hui S, Wang J, et al. Quantifying Unmet Need in Statin-Treated Hyperlipidemia Patients and the Potential Benefit of Further LDL-C Reduction Through an EHR-Based Retrospective Cohort Study.  J Manag Care Spec Pharm 2019 May; 25(5):544-554.
  9. Salami JA, Warraich H, Valero-Elizondo J, et al. National Trends in Statin Use and Expenditures in the US Adult Population From 2002 to 2013.  Insights from the medical expenditure panel survey.  JAMA Cardiol 2017; 2(1):56-65.