Friday, 25 May 2018

You are here

60 Minutes Drills Acthar - A Financially Crippling Drug

Acthar is in the news again. Previously a New York Times article lambasted the drug as the "single most expensive drug per patient", based on it costing Medicare  $16,2371 per patient for nearly 3100 patients. Overall, costing Medicare a half-billion US dollars per year. (Citation source: https://t.co/cskPO7OM1E)

In the current 60 minutes TV report by Leslie Stahl, she investigates what happened when the city of Rockford, IL, a city that funds its own insurance, had to pay for 2 children with infantile spasms who were prescribed Acthar.

The mayor, Larry Morrissey, found out that the city's health care budget was going bust because of pharmaceutical costs and that most of the cost was due to one drug, Acthar. 

The report reviews the outrage and consequences of drug pricing. Acthar use to be sold for ~$40 a vial in 2001, but today: the costs is more than $40,000 per vial. That's an increase of 100,000%. This price increase was enacted by the drug's previous owner, Questcor, which Mallinckrodt bought in 2014.

The company has been accused of price fixing. Last year the Federal Trade Commission charged the drug manufacturer, Mallinckrodt, with violating antitrust laws in order "to maintain extremely high prices for Acthar." This was done when it acquired their only competitive drug, Synacthen, that sold in Canada for $33.

Mallinckrodt settled the case and agreed to pay $100 million to the FTC. 

Since acquiring the drug from Questor, Mallinckrodt has even raised the price by about $8,000 a vial.

Acthar (ACTH: adrenocorticotropin hormone) was approved by the FDA in 1952 -- when drug companies were only required to demonstrate a drug's safety, not its efficacy.  Currently it is marketed by the company for:

  • Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus
  • Monotherapy for the treatment of infantile spasms in infants and children under 2 years of age
  • The treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown H.P. Acthar Gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease
  • Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
  • Treatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis)
  • The treatment of symptomatic sarcoidosis
  • Adjunctive therapy for short‐term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low‐dose maintenance therapy), ankylosing spondylitis
  • Treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation

 

 

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Trump Blasts Drug Makers on the Price of Drugs

Reuter's reports Friday that President Donald Trump blasted drugmakers and healthcare “middlemen” for making prescription drugs unaffordable for Americans. Nonetheless, many healthcare stocks rose as it became clear the administration had avoided taking aggressive and direct measures to cut drug prices.

Here are many New Sources on this developing story:

Patients May Not Fill Your Prescription

A new study linking administrative claims and electronic health records (EHRs) shows that nearly 40% of patients fill and take newly prescribed methotrexate (MTX), tofacitinib or biologics. 

Kan et al set out to estimate the extent and predictors of primary nonadherence in rheumatoid arthritis (RA) patients who received new prescriptions for methotrexate, biologics or tofacitinib.

Fish Oil Fails in Dry Eye Trial

Many topical and OTC products are recommended when treating chronic dry eyes, including omega-3 fatty acids (fish oil or n−3 fatty acids) to relieve symptoms; the NEJM reports that the DREAM trial shows no clinical benefit of n−3 fatty acids for 12 months when compared to placebo.

FDA Advisors Weigh COX-2 Inhibitor Safety

Should celecoxib (Celebrex) be officially declared as no riskier for the heart than other non-steroidal anti-inflammatory drugs (NSAIDs) naproxen and ibuprofen, and do those other NSAIDs interfere with aspirin for cardiovascular prevention?

Will Aspirin Cotherapy Undermine Celecoxib’s Safety Effects?

The PRECISION study took 11 years and 24,081 patients (90% OA; 10% RA). It showed that celecoxib had fewer gastrointestinal events, fewer renal events and less ATPC cardiac events compared to ibuprofen - with an 18% reduction in major CV events and a 32% reduction in all-cause mortaility compared to ibuprofen.