The first pathway (Pathway One) for prescription drug importation is being implemented under a statutory provision in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that has been in place since 2003 – Section 804 of the FD&C Act, which is codified at 21 U.S.C. § 384.

However, no previous HHS Secretary has been willing to certify, as required by the law, that drug importation would “pose no additional risk to the public’s health and safety” and would “result in a significant reduction in the cost of covered products to the American consumer.” (And although such a certification has not yet been provided to Congress, HHS indicates that it will take that step if and when the new proposed rule is finalized.)

Because of that existing law, FDA refers to the proposed programs that may be authorized by the agency as “Section 804 Importation Programs.” In a press conference before the release of the two documents on December 18th, Secretary Azar indicated that states such as Colorado, Florida, Maine, New Hampshire, Vermont, and Michigan have expressed interest in setting up their own importation programs.

We know that Florida submitted a plan to HHS in August 2019 even before the federal government had made any detailed proposals under Section 804. Colorado expects to submit its plan to HHS by January 15, 2020, and, under a state law, Maine has until May 1, 2020, to submit its importation plan for federal review.

FDA released the Notice of Proposed Rulemaking (NPRM) for Pathway One in order authorize imports of eligible prescription drugs from Canada on December 18, 2019, as noted above. The proposed rule would create a new Part 251 in Title 21 of the Code of Federal Regulations (CFR) pursuant to the authorities available in Section 804 of the FD&C Act.

Accordingly, some of the requirements included in the NPRM come directly from the language of the statute, while others are being proposed pursuant to the discretion granted to the HHS Secretary to require any other elements in a foreign importation plan as he deems necessary to protect the public health.

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Always include a semi-annual market check in your PBM contract language. Market checks provide each payer the ability, during the contract, to determine if better pricing is available in the marketplace compared to what the client is currently receiving.

When better pricing is discovered the contract language should stipulate the client be indemnified. Do not allow the PBM to limit the market check language to a similar size client, benefit design and/or drug utilization. In this case, the market check language is effectually meaningless.

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Pharmaceutical companies have paid doctors billions of dollars for consulting, promotional talks, meals and more. A new ProPublica analysis finds doctors who received payments linked to specific drugs prescribed more of those drugs.

Doctors who receive money from drugmakers related to a specific drug prescribe that drug more heavily than doctors without such financial ties, a new ProPublica analysis found. The pattern is consistent for almost all of the most widely prescribed brand-name drugs in Medicare, including drugs that treat diabetes, asthma and more.

Tyrone’s Commentary:

My pharmaceutical career began as a drug sales rep for Eli Lilly and Company in 2002. Detailing is a marketing technique used by pharmaceutical companies whereby drug sales reps educate a physician about a drugmaker’s products in hopes that the physician will prescribe the company’s products more often. 

Detailing is not a perfect concept. I would say, however, detailing is a necessary sub-step in the continuum of care. I recall several times when a new product hit the market and the physician had not even heard of it. I was his/her first introduction to the new product. These were products for which some of their patients would benefit from right away. 

It is when less costly therapeutic alternatives are not prescribed in favor of more costly prescription drugs I have a problem. At Lilly my first product was Actos an oral anti-diabetic for type 2 diabetes. My message to physicians was to use it as a second line agent after a patient failed on Metformin or Sulfonylurea. Because Actos was a branded product and much more expensive than Metformin, this was the right thing to do and proof detailing can be positive.

A cost-effective formulary takes precedence over physician detailing so much of the criticism is misdirected. If you want to prevent drugs from being prescribed, which have lower cost therapeutic alternatives, tighten up your benefit design.   

The financial interactions include payments for delivering promotional talks, consulting and receiving sponsored meals and travel. The 50 drugs in the analysis include many popular and expensive ones. Thirty-eight of the drugs have yearly costs exceeding $1,000 per patient, and many topped the list that are most costly for the Medicare Part D drug program.

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In an announcement Thursday night, Express Scripts and Prime Therapeutics said their new three-year collaboration is “designed to deliver more affordable care for clients and their members by enhancing pharmacy networks and pharmaceutical manufacturer value.”

The collaboration will allow Prime’s member Blue Cross health plans to gain leverage through Express Scripts’ buying clout and large pharmacy network. Express Scripts will handle negotiations for drugs on the pharmacy benefit.

Source: Becker’s Hospital Review

Tyrone’s Commentary:

This collaboration is a prelude to a complete acquisition of Prime. It’s smart to take baby steps which permits the attention to die down and to keep the regulators at bay for a while. This will allow ESI to win even larger discounts from drugmakers. Let’s hope they pass these savings back to their clients without punishing independent pharmacies.

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Always include a semi-annual market check in your PBM contract language. Market checks provide each payer the ability, during the contract, to determine if better pricing is available in the marketplace compared to what the client is currently receiving.

When better pricing is discovered the contract language should stipulate the client be indemnified. Do not allow the PBM to limit the market check language to a similar size client, benefit design and/or drug utilization. In this case, the market check language is effectually meaningless.

Clogged Artery

New research indicates that heart disease patients with blocked coronary arteries who received only drug therapy did not have more heart attacks or die more frequently than individuals who also received bypass surgery or stents. The findings, presented at the annual meeting of the American Heart Association on Saturday, held true for individuals with several severely blocked coronary arteries. Stenting and bypass procedures were helpful for some patients with angina, however.

Tyrone’s Commentary:

When properly prescribed and administered, prescription drugs are a cost offset opportunity

The more than 5,100 participants were followed for a median of 3.5 years. There were 145 deaths in the group that was randomized to receive stents or bypass in addition to medical therapy, compared with 144 among those who received medication alone. Additionally, there were 276 heart attacks in the stent and bypass group, vs. 314 in the medication group, a difference that was not considered significant.

Glenn Levine, MD, director of cardiac care at Baylor College of Medicine in Houston and a member of the guidelines committee of the American Heart Association, said the trial is “extraordinarily important” and the results will be incorporated into treatment guidelines.

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Always include a semi-annual market check in your PBM contract language. Market checks provide each payer the ability, during the contract, to determine if better pricing is available in the marketplace compared to what the client is currently receiving.

When better pricing is discovered the contract language should stipulate the client be indemnified. Do not allow the PBM to limit the market check language to a similar size client, benefit design and/or drug utilization. In this case, the market check language is effectually meaningless.

Tyrone’s Commentary:

I wrote about Diplomat’s demise just four weeks ago in my blog post, “Holy cow! Diplomat Pharmacy is a shell of its former self.” This was a fire sale $300M plus $400M in debt for a company which did over $5B in annual revenue. I hate to see them go it makes it tougher to compete with the Big Three. But, victory will be even sweeter when they [Big Three] are eventually humbled. Let this serve as a warning to those seeking to enter the PBM market. It is not nearly as easy as you think it is.

Diplomat has a track record of providing specialty pharmacy and infusion services, analysts said, but ran into trouble developing a pharmaceutical benefits management (PBM) business. Diplomat was founded in 1975 and employs about 2,200 people. The company operates in 50 states and dispensed 918,000 prescriptions last year, generating annual revenue of $5.5 billion. But Diplomat saw a net loss of $302 million last year due in part to client losses in the PBM business.

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