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www.biospace.com/News/this-years-5-mo... This Year’s 5 Most Expensive Drugs, Plus One12/19/2016 7:27:50 AM
This Year’s 5 Most Expensive Drugs, Plus One December 19, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Drug pricing became a hot topic in this year’s presidential election, spiked by Martin Shkrelli and Turing Pharmaceuticals’ 5,000-times price hike of Daraprim, a drug to treat Toxoplasmosis. It was helped along by concerns over Valeant Pharmaceuticals (VRX)' many drug-pricing troubles and Mylan NV (MYL) increasing the price of its EpiPen from $57 to almost $500. Keith Speights, writing for The Motley Fool, looks at the five most expensive prescription drugs of 2016.
1. Sovaldi
Sold by Gilead Sciences (GILD), Sovaldi runs about $75,600 for a 30-day regimen. It’s something of a miracle drug, essentially curing most cases of hepatitis C (HCV) in patients with genotypes 1, 2 and 4, with a 90 percent cure rate, and genotype 3, with an 84 percent cure rate. In 2014, Sovaldi generated $10.3 billion, and in 2015, dropped to $5.3 billion, largely as the result of the introduction its follow-up product, Harvoni.
2. Harvoni
Harvoni’s 30-day price is $74,000. It generated sales of about $13.9 billion in 2015. The cure rates are higher than those for Sovaldi, and didn’t require a combination therapy.
Speights writes, “However, in some ways, Harvoni’s success came too quickly and too intensely for Gilead. During the first nine months of 2016, sales for the HCV drug fell nearly 30 percent compared to the prior year period. A key challenge was that the sickest patients began using the drug immediately after it became available. Many were cured and no longer needed treatment.”
A good thing for patients, a challenge for the company.
3. Cinryze
Developed by Lev Pharmaceuticals, which was bought by ViroPharma, which was acquired by Shire Pharmaceuticals (SHPG) in 2013. Cinryze is used to treat swelling and pain in patients with hereditary angioedema. It is injectable, and runs about $72,100 for a 30-day supply.
Drugs for rare so-called orphan diseases, are typically high-priced, simply because there are rarely competitive drugs. As a result, insurers are willing to pay for them since they’re the only game in town, and the high price helps cover the expenses of developing a drug for a small market.
Speights writes, “Although HAE is a rare genetic disorder that affects no more than one in 10,000 people, Cinryze has been a big moneymaker for Shire.” In 2014, sales totaled $503 million, and in 2015, hit $618 million.
4. H.P Acthar
This drug received approval by the U.S. Food and Drug Administration (FDA) in the 1950s, and currently is priced at $51,600 for a 30-day supply. Speights writes, “The controversy about H.P. Acthar stems both from its price and its efficacy. Mallinckrodt (MNK) markets the drug as a treatment for 10 indications. H.P. Acthar is approved for 19 indications. Some payers have balked at reimbursing the drug for any indication other than infantile spasms. Despite these headwinds, Mallinckrodt made $1.16 billion from H.P. Acthar in its last fiscal year.”
5. Daklinza
Daklinza is a drug for hepatitis C like Sovaldi and Harvoni marketed by Bristol-Myers Squibb (BMY). It received FDA approval in 2015. It runs $50,700 for a 30-day regimen.
Speights writes, “Did Bristol’s win with Daklinza negatively impact Gilead (GILD)? Not at all. The U.S. Food and Drug Administration (FDA) approved the drug only in combination withi Sovaldi in treating HCV genotype 3. While Bristol made $1.3 billion with Daklinza in 2015, Gilead was also making money with every sale.”
6. Exondys 51 (eteplirsen)
Although Speights doesn’t mention it, in a discussion of expensive drugs, Sarepta Therapeutics (SRPT)’s Exondys 51 should be identified. This year marked a long and complicated saga as the FDA faced internal battles and external pressures to approve its drug for Duchenne Muscular Dystrophy (DMD).
Exondys 51 is priced at about $300,000 for a year’s treatment, with that number based on the weight of the patient. For the most part, insurers have agreed to pay for the treatment. One major exception is insurance company Anthem, which has 38 million health care customers. Anthem chose not to pay for it, arguing that it is “investigational and not medically necessary.”
Humana agreed to cover the drug, but only for a six-month treatment if it’s covered by initial approval. It will cover the second six months if the patients continue to be ambulatory.