Trump's four executive orders to lower drug prices: what does this mean for value-based contracting & innovative drugs?

On Friday, President Donald Trump signed four executive orders aimed at lowering the high cost of prescription drugs in the United States. Our COO, Nico Mros, dives into the four executive orders.

“The four orders I’m signing today will completely restructure the prescription drug market in terms of pricing and everything else to make these medications affordable and accessible for all Americans,” Trump said at the White House last Friday.

Trump goes on to state that Americans often pay up to 80% higher prices for prescription drugs than countries like Germany and Canada.

And while the timing seems anything but coincidental, Lyfegen does not intend to discuss political views but rather understand what this could mean specifically for healthcare innovation, value-based contracting and the patients whose life depend on access to innovative therapies.

Let us briefly and in simple terms dissect the four executive orders, which are subject to the regulatory review process post Friday’s signature:

The first order targets high insulin prices and EpiPens, requiring federal community health centers to pass discounts they receive directly to patients.

The second order would allow states, pharmacies and wholesalers to import drugs from Canada, where prices are drastically lower. Importing drugs would increase competition and cause drug prices in the United States to decrease. Up until now, prices were maintained high because importing medications from other countries for personal use was illegal according to the Food and Drug Administration.

The third order is aimed at preventing “middlemen,” more commonly known in healthcare as health plan sponsors and pharmacy benefit managers (PBMs), to pocket “significant discounts” negotiated — these being “up to 50 percent of the cost of the drug” while retailing them without a discount.

The fourth order, which has been signed but is being held back until Aug. 24 to give the healthcare industry time to “come up with something” to reduce drug prices, would allow Medicare to purchase drugs at the same price as other countries by implementing a “international pricing index”.

The international pricing index would align U.S. prices to those of other countries, such as Britain, France and Canada – countries where the cost of the same drugs are substantially lower because Governments cap drug prices.

So what does this mean for pharmaceutical innovation?

Simply aligning prices to countries where governments cap drug prices (in the case of the fourth executive order) or opening the import of prescription drugs from neighboring countries (in the case of the second executive order) will result in billion dollar losses for pharmaceutical companies within the next decade, increasing the risk of losing the funds necessary to drive innovation substantially (specifically the Research & Development of cutting edge innovative therapies).

“We pay for all of the resources and all of the development and foreign countries pay absolutely nothing,” Trump said. “Americans are funding the enormous cost of drug resource for the entire planet.”

But could this mean that pharmaceutical companies, trying to compensate their losses, would (or better said, should) be forced to focus on the root problems of healthcare pricing and come up with more wide-spread innovative pricing models for a more sustainable future.

Value-based contracting and technological solutions, such as those of Lyfegen, could support such a future.

In a world where value-based pricing is the norm, world leaders would not only look over to neighboring countries for pricing levels but rather would have to focus on the value of drugs and how they improve patient health outcomes.

Pharmaceutical company executives were scheduled to meet at the White House today to discuss the executive orders but the meeting was cancelled. Moving forward, one can only hope that healthcare innovation can start coexisting with sustainable expenditure and patient access.

Sources:https://www.whitehouse.gov/presidential-actions/executive-order-access-affordable-life-saving-medications/

https://www.whitehouse.gov/presidential-actions/executive-order-increasing-drug-importation-lower-prices-american-patients/

https://www.whitehouse.gov/presidential-actions/executive-order-lowering-prices-patients-eliminating-kickbacks-middlemen/

https://www.nytimes.com/reuters/2020/07/27/us/27reuters-usa-trump-drugprices-explainer.html/

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Study: Out-of-pocket drug costs increasing 5.8% per year

A new study investigated how drug rebates affect out-of-pocket costs for health plan beneficiaries. Rebates lower costs for payers, but depending on the health plan, they can raise costs for the patient.

There is a lot of secrecy surrounding the final price paid for a drug at the pharmacy, as official data on drug prices does not factor in rebates or the end price for the patient. The rebates paid by manufacturers to pharmacy benefit managers is not publicly available. The study therefore sought out to understand the relationship between rebates and the prices paid by insurers and beneficiaries.

Results: The negotiated price, defined as the price paid by the beneficiary at the pharmacy and by the payer after rebates are taken into account, rose 4.3% from 2007 to 2020. However, the out-of-pocket price, or that paid by the patient at the pharmacy, rose 5.8% annually. Retail pharmacy prices increased 9.1% annually.

Implications: Low-income families may be especially impacted by plans with higher deductibles and lower premiums, as they are not prepared for surprise costs associated with cost-sharing. As the authors stated: “consumers with a low deductible or capped copays appear to be shielded from steep pharmacy price increases.” The main contributor to increases in out-of-pocket expenses were increasing deductibles and co-insurance payments.

The authors emphasize that drug price transparency is important for health policy recommendations and more work needs to be done to understand drug price inflation.

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Ongoing debate around GLP-1 drug coverage

Payers are seeing increased costs due to the demand of GLP-1 drugs. It’s estimated that 57.4 million adults under the age of 65 could be eligible for this class of drugs, based on currently approved FDA indications. There are 36.2 million people with an obesity diagnosis alone in the US.

If 10% of eligible adults take GLP-1 medications for weight loss, a $15 increase could be seen in the per-member-per month costs. This number rises to $50 if one-third of eligible adults start taking these drugs. Zepbound, manufactured by Eli Lilly, has a list price of $1059 per month, whereas Novo Nordisk’s Wegovy costs $1349 for a one month supply. However, last month, Eli Lilly announced a major price cut for their weight loss drug. Now, a 4-week supply of their drug at 2.5 mg will cost $399, whereas 5 mg vials will cost $549.

The measure is aimed at improving patient access, while reducing the risk of counterfeit medications. This price reduction was made without changes to insurance policies, and the drugs are available through LillyDirect, the company’s online pharmacy.

Not all insurers want to cover weight loss drugs like Zepbound, Wegovy, Mounjaro, and Ozempic, and innovative strategies are being explored to manage costs while keeping them available. One strategy is a utilization cap, which sets stricter standards for who is eligible. Another strategy is mentioned in Evernorth’s EncircleRX plan, which provides a 15% cost cap or a 3:1 savings guarantee when the medication is covered for weight loss.

The value of these drugs is still being investigated. If these medications can provide additional health benefits, there could be additional savings for payers down the road. Of note, studies have found reductions in cardiovascular death and sleep apnea when the drugs were used for weight loss.

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