Life’s certainties include death and taxes. Now, according to a recent report, it seems we can add drug-price increases to the list.
Over time, brand name and generic drug prices can increase significantly, sometimes prompting policymakers to intervene. For example, California and Vermont now require drug manufacturers to justify increases above a certain level.
Without uniform regulations, what happens when drugmakers fail or refuse to justify price hikes?
The Institute for Clinical and Economic Review (ICER) has been tracking this issue since 2019. Every year, the institute publishes a report detailing the drugs that have increased in price without justification.
In the institute’s third report, published in November 2021 (and updated in December), eight out of 250 drugs were deemed to have “price increases unsupported by new clinical evidence” in 2020. Authors noted that seven of those drugs accounted for an annual increase in spending of $1.67 billion. (An estimate for the remaining drug was not attained). The figure far exceeds the same measure from 2019, during which US drug spending increased by $1.2 billion due to seven drugs with unsupported price increases.
Interestingly, this doesn’t represent a broad trend. According to ICER, data suggest that overall net prices for drugs in the US market have decreased over the past several years. Authors of the report point out that price increases tend to occur in drug categories where competition is limited. For medications related to oncology or atypical antipsychotics, for example, product substitution can be tricky.
Here are the eight drugs included in the report that had “unsupported price increases that have added significant costs to national drug spending” in 2020.
1. Humira (adalimumab, AbbVie)
Approved by the FDA in 2002, this humanized monoclonal antibody binds to tumor necrosis factor (TNF). It’s used in the treatment of nine different chronic diseases, including rheumatoid arthritis, Crohn disease, and ulcerative colitis.
In 2020, the net price increase of the drug was estimated at 9.6%, resulting in additional national spending of more than $1.3 million. The report found that there was no new clinical evidence to support the increase in price, and authors noted that a recent study failed to address concerns over an elevated risk of major birth defects with adalimumab.
2. Promacta (eltrombopag, Novartis)
Promacta is a small molecule thrombopoietin receptor used to treat thrombocytopenia in patients with chronic hepatitis, and in those who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Approved by the FDA in 2008, the drug is also applied in the treatment of severe aplastic anemia in patients who have had an insufficient response to immunosuppressive therapy.
The drug’s net price increased by 14.1% during 2020, resulting in an estimated increase in drug spending of $100 million. The report found no new moderate to high-quality evidence on the benefits and/or harms of the drug.
3. Tysabri (natalizumab, Biogen)
The FDA approved this integrin receptor antagonist in 2004. It’s a treatment for relapsing forms of multiple sclerosis and moderate-to-severe Crohn disease in patients who don’t respond to conventional therapy.
Its net price increased by 4.2% during 2020, for an increase in drug spending of $43.6 million. Authors reviewed any possible new safety and clinical effectiveness information and found that none of the 35 references submitted by the manufacturer met their criteria of moderate to high-quality evidence.
4. Xifaxan (rifaximin, Bausch Health)
Xifaxan is a rifamycin antibacterial drug used to treat traveler’s diarrhea caused by noninvasive strains of Escherichia coli, irritable bowel syndrome with diarrhea, and for the reduction in risk of overt hepatic encephalopathy recurrence in adults. Originally approved by the FDA in 2004, the drug’s net price increased by 3% during 2020, resulting in $43 million in new spending.
The authors found no new evidence of the safety and clinical effectiveness of the medication to justify its price hike.
5. Trokendi XR (topiramate, Supernus Pharmaceuticals)
The FDA approved Trokendi XR in 1996. The carbonic anhydrase inhibitor is an extended-release formulation approved for epilepsy, specifically as a monotherapy and adjunctive treatment in seizures classified as partial-onset or primary generalized tonic-clonic.
During 2020, the drug’s net price increased by 8%, leading to an estimated increase in drug spending of $36 million. While the report did identify new evidence of the drug’s effectiveness, researchers deemed it low quality and concluded it did not justify the price hike.
6. Lupron Depot (leuprolide acetate, AbbVie)
Lupron Depot is a gonadotropin-releasing hormone agonist used in the palliative treatment of advanced prostatic cancer, for the management of endometriosis, and preoperative hematologic improvement of women with anemia. Originally approved in 1985, the drug’s net price increased by 5.9% in 2020, resulting in a $30 million increase in drug spending.
Authors found that, of all the new materials available, none met the criteria of moderate to high-quality evidence to justify the price hike.
7. Krystexxa (pegloticase, Horizon Therapeutics)
The FDA approved Krystexxa in 2010. This PEGylated uric acid-specific enzyme is used to treat chronic gout in patients who don’t respond to conventional therapy.
The net price of the drug increased by 5.2% during 2020, which led to an increase in drug spending of $19 million. Authors found no new information on the safety and clinical effectiveness of the drug that would have justified the increase in price.
8. Emflaza (deflazacort, PTC Therapeutics)
Emflaza, which the FDA approved in 2017, is a corticosteroid used to treat Duchenne muscular dystrophy. The authors were not able to estimate an increase in the drug’s net price. However, they did ascertain that the product’s net revenue in 2020 was $139 million, which is a 38% increase compared with 2019.
As with the drugs listed above, the authors found no new clinical evidence relating to the safety or effectiveness of Emflaza. They concluded the price hike was unsupported.