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Cardiovascular drugs are among the most widely used, since their indications are far reaching and address conditions that are prevalent among a large population.
Cardiovascular drugs are among the most widely used, since their indications are far reaching and address conditions that are prevalent among a large population. In fact, approximately 5.1 million Americans have heart failure, according to the Centers for Disease Control and Prevention.
According to the “2015 Drug Trend Report,” from Express Scripts, spending on drugs in the cardiovascular categories decreased between 2014 and 2015.
The Drug Trend Report found that spending in the high blood cholesterol class decreased 9.2% because of decreases in both use and unit cost. This decrease moved this class to the third most costly traditional therapy class in 2015 from second in 2014. Per-member-per-year (PMPY) spend was $32.66.
The decrease in trend is greatly influenced by the availability of generic medications, which represent 83.1% of the market share in the class, according to the report. Additionally, spending in the high blood pressure/heart disease category decreased 12.5% between 2014 and 2015, driven mostly by a 14.9% decline in unit costs. Generic medications make up 95.7% of the 2015 market share for the class. The high blood pressure/heart disease category is the fifth costliest traditional class of medications, with PMPY spend of $25.70.
PetersonGiven the large population of Americans with high blood cholesterol, new innovation in this category has the potential to significantly increase spending in this class, which is currently dominated by low-cost, effective statin therapies, according to Christopher Peterson, PharmD, senior director, clinical evaluation and policy at Express Scripts.
“However, the drugs in the high blood cholesterol pipeline, if approved, would generate competition among the new class of cholesterol-lowering medications [PCSK9 inhibitors]…which could help make them more affordable,” Peterson says.
DiStefanoPCSK9 inhibitors, evolocumab (Repatha, Amgen) and alirocumab (Praluent, Sanofi/Regeneron), are new cholesterol busters that entered the market in the second half of 2015. These new medications are only appropriate for a small number of patients with very specific and rare forms of high cholesterol that is unresponsive to available statin therapy.
Given the high price tag for these drugs-more than $14,000 per year before discounts-it’s important for payers to ensure appropriate use, according to Express Scripts.
“PCSK9 inhibitors will provide more negotiating room for managed care teams to implement one or the other onto preferred formularies,” says Dan DiStefano, PharmD, clinical pharmacist, director of specialty pharmacy, Curexa Pharmacy. “These [drugs] are more than 10 times the price per month when compared to other drugs to treat the same condition.”
In 2015, the first of a new class of heart failure medications was released to the marketplace, demonstrating opportunities for both manufacturers and pharmacies to provide new and exciting therapies to patients.
These drugs, sacubitril/varsatan (Entresto, Novartis) and ivabradine (Corlanor, Amgen), could drive spending in this category, experts say.
“Considering that Entresto and Corlanor are higher-dollar, brand-name drugs without generics available or a specific therapeutic substitution, managed care is undoubtedly facing an increased spend per patient diagnosed with heart failure,” says DiStefano. “Despite these medications being higher dollar, their effectiveness may be able to decrease overall healthcare costs via decreased hospitalizations.”
Novartis is testing an outcomes-based pricing model with Entresto, whereby payers initially get the drug at a discount but then pay Novartis more if, as expected, it successfully reduces the need for costly hospital visits. The company reportedly reached agreements with Anthem and Aetna about connecting the pricing of its heart failure drug with patient outcomes.
“This is a real shift in the pharmaceutical business,” says Ash Shehata, KPMG’s advisory leader for health plans. “Collecting this sort of information is not easy, but it is a matter of agreeing upon the same standards around measuring outcomes and having the analytic tools to do so. Heart failure created a unique opportunity to do so, since this group of patients typically has high hospitalization costs and a need to drive savings.”
This new pricing approach is indicative of a trend occurring throughout industry, where payers are looking to shift risk to hospitals and payment for quality outcomes is trying to gain traction, Shehata says.
“Express Scripts welcomes all ideas that aim to better tie a drug's price to the value it provides,” says Jennifer Luddy, a spokesperson for the PBM. “The potential pitfall of many outcomes-based proposals is that they create an administrative burden that is costlier than the discount they may achieve. The benefit of our indication-based approach, currently for oncology, is that it does not require plans to track the specific outcomes of a patient and to reconcile payments with drugmakers long after-the-fact.”
Payers are setting a strict prior authorization policy for the new heart failure drugs, which makes it difficult for new patients to receive prescribed therapies, says DiStefano.
“Cardiologists do not have the office resources to support such an intense payer process, thus pushing cardiologists away from prescribing,” he says.
Still, says Peterson, ensuring appropriate use is paramount for payers looking to control spend in this category. “As mentioned previously, PCSK9 inhibitors, Repatha and Praluent, are only appropriate for a small number of patients with very specific and rare forms of high cholesterol that is unresponsive to available statin therapy.”
Peterson cites Express Scripts’ Cholesterol Care Value Program, which combines discounts on the PCSK9 therapies with rigorous utilization management for both drugs in the class, and offers additional protection by capping plan cost in 2016, as holding down current spending on these drugs.
The pipeline for treating high blood cholesterol is limited, according Peterson. “Development has transitioned away from statins, the gold standard for treating high cholesterol,” Peterson says. “Patent expirations continue to impact this class.”
The first generic for rosuvastatin (Crestor, AstraZeneca) was approved in April. Multiple generics to Crestor are expected to launch about two months later, according to Peterson.
Ezetimibe [Zetia, Merck] is expected to go generic on December 12, 2016, Peterson says. “Annual sales for these products are $6.4 billion and $2.3 billion, respectively.”
Included in the pipeline for high blood cholesterol are:
Anacetrapib (Merck). This oral cholesteryl ester transfer protein (CETP) inhibitor could be approved in 2017. “It would be used in combination with statins-most of which are generically available-to provide additional LDL cholesterol lowering [39%], says Peterson. “The drug can also raise HDL cholesterol by 138%.”
Despite failures of all other CETP inhibitors previously in development, an independent data monitoring committee recommended the drug’s “Randomized Evaluation of the Effects of Anacetrapib Through Lipid-modification” trial continue without changes. The study readout is scheduled for 2017.
Bococizumab (Pfizer). This could be the next injectable PCSK9 inhibitor, competing with Repatha and Praluent for market share, according to Peterson.
“These injectable products are used as add-on therapy to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C,” he says. “The availability of an additional PCSK9 inhibitor could offer additional competitive cost savings within the category.”
This becomes more important when the cardiovascular outcomes data surrounding the use of these drugs becomes available, the first of which may be as early as the end of 2016, as Amgen’s “Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk” study is expected to complete earlier than expected.
“A positive outcomes trial will increase the demand for these drugs, possibly in a larger subset of patients,” Peterson says.
The pipeline of drugs for treating high blood pressure is also limited, says Peterson. This class is highly genericized. “Many of the medications have extensive data surrounding their efficacy and safety,” he says. “It will be difficult for a new medication to make a significant impact within this therapy class. However, patent expirations still continue to impact trend.”
Generics for Daiichi Sankyo’s Benicar (olmesartan medoxomil) are expected to become available on October 26, 2016. This is the last large-selling angiotensin receptor blockers (ARBs) to lose patent protection, according to Peterson. Benicar and Benicar HCT (combined with hydrochlorothiazide) had annual sales of approximately $1.845 billion in 2015.
In addition, Merck’s vericiguat, an investigational stimulator of soluble guanylate cyclase (sGC), is currently in phase 2b for treatment of heart failure.
Finerenone (Bayer), a non-steriodal antimineralocortcoid receptor antagonist (BAY 94-8862) is in phase 3 trials for chronic heart failure.
Tracey Walker is content manager for Managed Healthcare Executive.