Andy Slavitt joins A Health Podyssey
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Tuesday, June 21, 2022 | The Latest Research, Commentary, And News From
Health Affairs

Dear John,

We hope you had a great weekend. We are still taking applications for
our open Associate Director of Digital Product Management position
.
Please share this listing with anyone you think would be a good fit.

Today's newsletter comes from the desk of William Feldman of Brigham and
Women's Hospital and Harvard Medical School. Feldman and colleagues
recently published an overview on inhaler patents and regulatory
exclusivities

in Health Affairs.

Inhaler Patents and Device Hopping

When I started my fellowship in pulmonary and critical care medicine in
2017, there were no generic inhalers for asthma or chronic obstructive
pulmonary disease (COPD) on the US market.

A colorful chart hung in our clinic listing the numerous brand-name
products by class, but there were no generics and, regardless of which
inhalers I prescribed, I heard a common refrain from patients: inhalers
were expensive!

For some patients, the costs were simply too great, and they would forgo
therapy, occasionally citing other concerns because they were too
embarrassed, I suspected, to acknowledge the financial strain.

The most perplexing component of the problem was that the drugs I was
prescribing had been around for decades: beclomethasone since 1976,
albuterol since 1981, ipratropium since 1986. Where were all the
generics?

These questions set me on a path, culminating in an article this month
in Health Affairs
,
to understand the barriers to generic entry in the inhaler market. Our
team built a database of every patent and non-patent exclusivity listed
in the Approved Products with Therapeutic Equivalence Evaluations (the
Orange Book) on inhalers approved by the FDA from 1986-2020.

During the study period, the FDA approved 53 different brand-name
products. Yet, through the end of 2021, only three of these brand-name
products had approved generics.

Despite the abundance of brand-name approvals, we found little in the
way of meaningful clinical innovation. The only product approved with a
new mechanism of action during the study period was Atrovent
(ipratropium) in 1986.

For the past thirty-five years, manufacturers have secured FDA approvals
by developing products with new active ingredients in the same class,
isolating enantiomeric precursors from racemic mixtures, creating
longer-acting versions of earlier products, and combining two or more
active ingredients into a single inhaler.

With only incremental changes, the inhaled products on the market today
all act on the same molecular targets as the inhaled products of the
1970s and 1980s.

Still, brand-name manufacturers have secured long periods of market
exclusivity for their products.

They have done so, in part, by obtaining patents on the inhaler devices
rather than the active ingredients contained within; more than 50
percent of all patents on inhalers in our cohort were device-patents.

Manufacturers have also engaged in a practice of "device hopping" or
shifting ingredients from one inhaler device to the next.

To take just one example, Boehringer Ingelheim received approval for its
Combivent (albuterol-ipratropium) inhaler in 1996 with patent protection
through 2015 and then obtained approval for Combivent Respimat in 2011
with patents lasting through 2030.

The company is currently enjoying 34 years of uninterrupted patent
protection for a product line with active ingredients that were
initially approved in 1981 and 1986, respectively.

Across all device hops in our study (spanning 14 originator products
with 18 follow-ons), the median duration from approval of the originator
product to the last-to-expire patent of follow-ons was 28 years.

Some of these device hops, including Combivent, it should be noted,
followed from an FDA ban on ozone-depleting chlorofluorocarbons (CFCs)
.
CFC-containing inhalers were initially exempt from the Montreal Protocol
(signed in 1987) until more environmentally friendly inhalers could be
developed.

With strong encouragement from the pharmaceutical industry
,
the FDA phased out CFC-containing inhalers between 2009-2013. While this
ban contributed to environment protection, it was implemented without
sufficient controls in place to limit costs.

Manufacturers have reaped billions of dollars of revenue
since the CFC-ban, far
outpacing the investments required for new CFC-free technology.

Perhaps more importantly, most of the device hops in our study involved
jumps not from CFC-containing to CFC-free inhalers but from different
types of CFC-free products. Sadly for our patients, these new devices
offer little demonstrated clinical benefit beyond existing therapy, and
yet keep costs high.

We are hopeful that our article in Health Affairs may provide
policymakers with new insights into the problems now confronting the
inhaler market.

Congress recently passed legislation
calling
on the FDA and the Government Accountability Office to examine patenting
strategies by brand-name manufacturers with a particular focus on
drug-device combination products like inhalers.

In our article, we consider several ideas for reform. Two excellent
accompanying perspectives-one by Robin Feldman
and
the other by Scott Hemphill and Bhaven Sampat
-lay
out further ideas and help put our findings into context.

Without reform, I worry that prices will remain high and the same
brand-dominated charts hanging on our clinic walls today will remain for
years to come.

**Read The Study**

[link removed]

Advertisement

Elsewhere At Health Affairs

Today in Health Affairs Forefront, S. Sean Tu and coauthors suggest
changing the patent reference listing process
,
which currently allows for the issuance of poor-quality drug patents
that reduce competition at the expense of patients' health and
finances.

Sean Dickson discusses how reforming the FDA's Paragraph IV
requirement

- a statement that the proposed generic drug will not infringe on any
patent that the brand manufacturer claims applies to the existing drug
- would align patent enforcement in the pharmaceutical sector with
other sectors, eliminating the ability of one low-quality, later-filed
patent to categorically bar all generic entry.

Elevating Voices: Pride Month: In a Health Affairs Forefront article
published in December 2021, Katie Keith discussed how a proposed 2023
payment rule would restore nondiscrimination protections

that were eliminated in 2020 and ensure that LGBTQ people are explicitly
protected from discrimination by exchanges, states, insurers, and agents
and brokers.

Advertise with Health Affairs this month to take advantage of our
current promotions. Learn more about advertising opportunities here
.

Currently, more than 70 percent of our content is freely available -
and we'd like to keep it that way. With your support
,
we can continue to keep our digital publication Forefront and podcasts
free for everyone.

[link removed]

Excursion: Andy Slavitt

Listen to Health Affairs Editor-in-Chief interview Andy Slavitt,
co-founder of both United States of Care
and Town Hall Ventures
and former administrator of the
Centers for Medicare and Medicaid Services.

Andy is the host of the podcast In The Bubble with Andy Slavitt

and recently published "Preventable: The Inside Story of How Leadership
Failures, Politics, and Selfishness Doomed the U.S. Coronavirus Response
."

Listen Here

[link removed]

Daily Digest

Patents And Regulatory Exclusivities On Inhalers For Asthma And COPD,
1986-2020

William Feldman et al.

Podcast: Andy Slavitt on A Health Podyssey

Reforming The FDA's Paragraph IV Requirement To Encourage Faster
Generic Drug Entry

Sean Dickson

Reference Check: A Simple Strategy To Improve Drug Patent Quality

S. Sean Tu et al.

 

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mailto:[email protected]

About Health Affairs

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Update .  

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