Costs of Innovative Drugs High in Primary Care

A popular session at ASHP 2016 Summer Meetings & Exhibition highlighted newer medicines prescribed for various disease states in primary care. During the 2-hour session, Tom Frank, PharmD, BCPS, provided a brief overview on some of these drugs, touching on clinical trials, adverse events (AEs), and economic costs.

“The high expense of these products will necessitate a strong focus on value-based equation,” said Dr Frank, director, research and education, University of Arkansas for Medical Sciences-Northeast.

High Cost of HCV Treatments

Recently, FDA-approved direct-acting antiviral drugs that attack the hepatitis C virus (HCV) have improved success rates for individuals, with cure rates over 90% in most patients. Dr Frank discussed two drugs in this class. 

Bristol-Myer Squibb’s Daklina (daclatasvir) is indicated for use with sofosbuvir for the treatment of patients with chronic HCV genotype 3. An open-label trial involving treatment-naïve and treatment-experienced participants with HCV genotype 3 infection evaluated daclatasvir plus sofosbuvir for 12 weeks and were monitored for 24 weeks after treatment. Sustained virologic response (SVR) was achieved in 98% of treatment-naive participants with no cirrhosis of the liver and 58% of the treatment-naive participants with cirrhosis. Of the participants who were treatment-experienced, 92% with no cirrhosis of the liver and 69% with cirrhosis achieved SVR. AEs include headache, fatigue, nausea, and diarrhea.

A 12-week course of daclatasvir runs about $75,000, he said, noting that Gilead Science Inc’s drugs Sovaldi (sofosbuvir) and Harvoni (edipasvir/sofosbuvir) cost about $84,000 and $94,000, respectively.

“The problem with these drugs is the economics. I think the conversation needs to be on who are the patients that will benefit from this to the greatest degree,” he said. “A lot of this [cost] is covered by public assistance, so it’s the taxpayers who are underwriting these therapies for many patients.”

He noted that competition in the marketplace may be driving down the price, as evidenced by the introduction of Merck & Co’s Zepatier (elbasvir and grazoprevir) at $54,600 for a 12-week regimen. The medicine is a fixed-dose combination antiviral indicated for use with and without ribavirin for chronic HCV genotypes 1 and 4.

Alirocumab vs Evolocumab 

Two cholesterol-lowering treatments in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors were discussed. Regeneron/Sanofi-Aventis’ Praluent (alirocumab) and Amgen’s Repatha (evolocumab) are both indicated in addition to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia, or patients with clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein (LDL) cholesterol. Evolocumab is also indicated as an adjunct to diet and other therapies for homozygous familial hypercholesterolemia in individuals who require additional lowering of LDL cholesterol. 

Alirocumab, evaluated in five placebo-controlled trials involving more than 2000 participants, demonstrated an average reduction in LDL cholesterol ranging from 36% to 59% compared with placebo. AEs associated with treatment include injection site reactions, myalgia, and muscle spasms. Evolocumab was also evaluated in multiple clinical trials. In one 12-week study of participants with heterozygous familial hypercholesterolemia, the evolocumab-treatment arm produced a 61% reduction in LDL cholesterol compared with placebo. AEs included upper respiratory tract infection, influenza, and back pain.

The cost of alirocumab is $14,600 a year, which is on par with that of evolocumab at $14,100 per year, according to Dr Frank.

High Cost Diabetes Treatment 

In recent years, the FDA has approved several new treatments for diabetes. One drug Dr Frank discussed was Tresiba (insulin degludec; Novo Nordisk). Insulin degludec is a long-acting insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Insulin degludec has been evaluated in nine randomized, controlled, treat-to-target, open-label trials in adults with type 1 and type 2 diabetes. 

The cost is $426 for the U-100 concentration and $511 for the U-200 concentration, he said, noting that the cost is high; however, “the good news is the dose pen is stable for eight weeks after it is opened.”

In conclusion, Dr Frank said, “Pharmacy benefit managers, accountable care organizations, and other third-party payers will look for multiple avenues to spread the financial burden of these products. Do the right thing and take care of the patient.”—Eileen Koutnik-Fotopoulos