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DTC-In-Perspective by Bob Ehrlich

Revolutionizing Pharma: The Rise of Direct to Consumer Pharmaceutical Drugs

December 3, 2024 0

One of the current trends in DTC marketing is the availability of some branded drugs shipped directly from the manufacturer. Some pharmaceutical companies are starting to cut the wholesalers and retailers out of the purchase cycle. While still in its infancy, the direct to consumer operations have enormous implications for how consumers will get their drugs in the future. Eli Lilly and Pfizer are the first to offer this service.

The direct sales of drugs to consumers have been in place for nearly a decade from non-pharmaceutical companies. Hims started in 2017, and there are now many non-pharmaceutical companies diagnosing, prescribing, and shipping to consumers. Drug companies have decided to enter direct sales in the past few years.

Why are drug companies now getting into the direct sales business? There are several good reasons for this new approach. First, drug makers are now seeing a huge growth in direct sales companies offering compounded versions of their drugs. These are cheaper and, in categories like weight loss, have lots of appeal to consumers. Second, cutting out the middlemen gives drug companies better ability to lower drug prices. Third, there are enormous marketing advantages to knowing your customers and tracking their purchases over time. Fourth, drug companies are concerned about counterfeit drugs through reimportation which is a real problem for consumers ordering from the internet. Fifth, consumers like the convenience of getting diagnoses and prescriptions without having to see their doctor in person.

“Cutting out the middlemen gives drug companies better ability to lower drug prices, know their customers, and combat counterfeit medications – reshaping how consumers access healthcare”

I would expect that drug companies will greatly expand their direct to consumer programs and use traditional DTC advertising to make consumers aware of their purchase options. The direct business will not replace retail drug stores or drug wholesalers for most drugs. Most of the growth will come from lifestyle categories like weight loss, sexual dysfunction, sleep disorders, migraine, anxiety, and depression. Any category where an online survey and virtual healthcare can diagnose a consumer condition is an opportunity for direct sales.

There are legitimate ethical and policy implications to expanding direct pharmaceutical distribution. The non-pharmaceutical direct business makes it easy to get prescription meds through an online survey or telemedicine that inappropriate prescribing is possible. I expect pharmaceutical companies will have better controls in place to make sure a prescription is justified. After all, these big pharma companies have a lot more to lose in public reputation and through regulatory, public policy, and legal actions.

The Amazoning of America has certainly shown that consumers love the convenience of shopping from home. Getting a diagnoses, prescription, and delivery online is becoming accepted for many drug categories. Drug companies see the potential and expect major growth in this channel.

Bob Ehrlich

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DTC-In-Perspective by Bob Ehrlich

Trump and Pharma

November 12, 2024 0

The election of Donald Trump is having pharmaceutical companies evaluate how things may change in terms of legislation and regulation. Trump is not yet clear on his moves regarding pharma. In his first term, he criticized the drug companies for pricing higher in the U.S. than other developed countries. Republicans in Congress have generally not allowed punitive legislation on price controls. They understand the negative impact price controls would have on R&D. Trump wants lower prices and that is publicly popular.  Acting on PBMs would be one option. Another would be allowing and promoting reimportation of drugs.

The DTC Industry should be nervous about Robert Kennedy Jr. being given a large role in healthcare policy. He said on 11/4 that he wanted to get Trump back in D.C. so they can “ban pharmaceutical advertising on TV.”  Scary comment. Kennedy is known for anti-vaccine sentiment and the desire to get corporate influence reduced. He is anxious to focus on prevention of disease which he feels is neglected in budgetary decisions. Kennedy thinks DTC advertisers exert influence on editorial coverage. Anyone who has watched news coverage knows the drug industry has not historically been favorably covered.

I doubt Trump will act on DTC advertising. He did not in his first term and a Republican Congress will recognize the free speech rights to advertise. I do expect Trump to speed up the regulatory drug approval process and that should be a net positive for innovation. In fact, expansion of drug use and DTC ads promoting such should help in the disease prevention goal of Kennedy.

Will FDA be asked by Kennedy and Trump to make DTC harder to execute? It is already harder with the latest OPDP rule recently implemented. Can it be made so restrictive that DTC ads are impractical? That is certainly a possibility, but the drug, media, and advertising agency lobby is strong and persuasive. Usually, the pro advertising forces have prevailed. Republicans have historically been pro-advertising, and I expect Trump not to act even if Kennedy proposes a ban.

Uncertainty is never helpful in DTC planning and the anti-DTC proponents will make a lot of noise. I remain confident, however, that no actions will be taken to ban or further restrict DTC.

Bob Ehrlich

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DTC-In-Perspective by Bob Ehrlich

DTC in Perspective: Drug Prices in DTC Ads? Bad Idea Gets Traction.

September 5, 2018 0

The Senate recently passed an amendment to a larger health care bill that requires drug prices be disclosed in DTC Ads. The Durbin amendment was adopted with bipartisan support. It really just gives HHS a million dollars to study a way to require the disclosure. What is clear is this idea has strong support from President Trump, Congress, HHS Secretary Azar, and the American Medical Association. So, like it or not, the drug advertisers may be forced to add some price information to ads.

Bob Ehrlich
“Drug makers may be forced to add… price information to ads.”
-Bob Ehrlich

On the surface, that list price disclosure seems reasonable. We see MSRP in car ads, so we know whether it is a premium or economy car. Not that we don’t know that already but it is not unreasonable. For cars, we know we will likely pay somewhat less than MSRP but we do know the range a Mercedes will cost us. Congress thinks consumers deserve to know the price of drugs they see advertised. To Congress that seems like it would help consumers decide if this advertised drug should be considered.

Drug pricing is not like car pricing. Consumers pay much less than the list price and sometimes pay nothing for the $50000 drug for cancer. Admittedly, drug pricing is a Byzantine process that confounds most of us. Each insurance company, PBM, and government payer negotiates prices. Each consumer depending on their insurance pays a different price no way near the list price. Sometimes the consumer would pay out of pocket more for their OTC cough medicine than the $50000 cancer drug.

So how should drug companies disclose drug prices? If the list price is not anywhere near what consumers pay, then how does disclosing it help them? It does not. It helps insurance companies in making DTC more difficult for drug companies to execute. The knowledgeable legislators know that if they force drug makers to talk about price that may discourage them from doing DTC Ads for expensive drugs. Drug makers advertising the $100000 cancer drug may decide that DTC is not worth trying to explain the complexities of drug pricing or face the barrage of criticism for having a sticker shock price.

I think this is the real reason for this amendment. Embarrassing drug companies they hope will put a chill on DTC for cancer drugs, biologics for arthritis, Crohn’s, and other new premium drugs. Of course, all drugs will face a guidance on how pricing needs to be discussed. Somehow FDA will make disclosure a time consuming step in a DTC ad. That will add 10-15 seconds to the ad and may make them difficult to execute. Their hope is to get drug companies to stop doing DTC.

So the good news is it will take FDA a while to study and draft guidance for disclosing price. This lag may allow the powerful advertising lobby to show how impractical this disclosure requirement will be. My guess is we may have some compromise that speaks in terms of ranges of price. That is something like “most patients will pay much less than the price listed depending on your insurance coverage.” Or, drug makers may be able to say “the average price paid by consumers is x.”

It may be illegal to require drug makers to disclose price under commercial free speech grounds. I am sure the advertising lobby will argue this inhibits commercial speech. They would have a strong case based on precedent.

My advice to the agencies is to be ready to deal with adding some price statement but I am sure it will be a few years before FDA can figure out how best to do this. They research everything they do and that will take a long time to study. DTC price disclosure sounds great but is just a bad idea that will not help patients.

Bob Ehrlich

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DTC-In-Perspective by Bob Ehrlich

DTC in Perspective: Keytruda Enters the DTC Arena

February 10, 2017 0

Merck’s cancer drug Keytruda recently began its DTC campaign competing with Bristol Myers’ Opdivo. What is significant is that highly targeted drug categories continue to invest heavily in DTC. Keytruda is a biologic injection that has indications for non small cell lung cancer, advanced melanoma and head and neck cancer.

Bob Ehrlich
“Keytruda has done an excellent job in its DTC ad.”
-Bob Ehrlich

The market is small by size compared to mega categories like diabetes and cholesterol where sufferers are in the tens of millions. Lung cancer cases number about 200,000 newly diagnosed annually. Of course, when the treatment price is around $100,000 per year for biologic lung cancer treatment versus less than a thousand for cholesterol drugs; the DTC payback is certainly achievable.

Roughly the numbers show a $50 million ad campaign for Opdivo and Keytruda need only gain 500 new patients from DTC to break even on a revenue basis. While consumers are the DTC apparent target, these ads also reach oncologists. Once an oncologist knows patients are seeing the DTC and will ask about the drugs, it clearly provides the motivation to consider using them.

The Keytruda ad is very different from Opdivo. While Opdivo used a headline dramatic announcement approach, Keytruda chose an individual patient story. Using an actor portrayal Keytruda showed a 60ish age woman named Sharon telling her story in a tv production studio. Sharon says she learned her type of lung cancer could be treated with an alternative to chemo. She tells how she was given only months to live but a year later after treatment she is still there with her family.

The commercial is filmed in black and white which adds to the seriousness of the presentation. Sharon’s story in this 90 second ad is told very well. It is very informative and understandable using Sharon and supers emphasizing the key benefits. What is interesting is that they are showing Sharon in the production studio both telling her story and in the makeup room preparing to be filmed. Her family is also at the studio watching her being filmed telling her success story.

The sell portion of the ad is about 30 seconds with fair balance risks and warnings in the last minute. Clearly the ad is technical in terms of disclaimers about who can take the drug and one wonders if patients who have non small cell cancer are aware of their biomarkers and gene types mentioned in the ad.

Given the high prices for treatment stock analysts see Keytruda generating revenue in the billions. A DTC campaign costing $50-100 million for a drug bringing in billions is a small risk for Merck. Opdivo had been criticized by some doctors for advertising to patients in an area best left for oncologists. This is a fair question but advertising breakthrough therapies does help potential patients become aware of their options. It also puts pressure on insurance companies to cover the large expense.

Keytruda has done an excellent job in its DTC ad. This campaign will get attention and is very different in executional style from Opdivo, an ad I also think is very good. The broader concern is whether advertising $100,000 drugs to consumers causes Congress to look more critically at both drug prices and DTC ads. While individual patients get extra months and in some cases years longer to live, government payers and insurance companies are paying a lot for that life extension. While no one wants to put a price on those months, unfortunately it is a calculation needed to be considered by policy makers.

Bob Ehrlich