Market Place
Nearly every
year, drugmakers ring in the new year with drug price increases in the US. This
year too, prices of over 450 prescription
medicines increased by an average of around 5 percent at the start of January.
This, when high drug prices have been one of the biggest political issues in
the US over the last few years.
PharmaCompass decided to usher in 2022 with a review of the US Medicare Part D Prescription Drug data recently released by the Centers for Medicare and Medicaid Services (CMS) for calendar year 2019. Using the available data, we have developed our own dashboard to show recent trends in consumption of prescription drugs. With this analysis, we hope our readers will get a better understanding of the world’s largest market for pharmaceuticals, as also a fix on where it may be headed.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Rising healthcare, drug spends in US
Over the
last several years, we have repeatedly heard political leaders in the US
complain about high drug prices. Yet, drug prices and healthcare spends have
risen unabated.
America’s National Health Expenditure Accounts (NHEA) includes annual expenditures on healthcare goods and services, public health activities, the net cost of health insurance, and investment related to healthcare. In 2019, America’s national health expenditure (NHE) grew by 4.6 percent to US$ 3.8
trillion, accounting for 17.7 percent of the gross domestic product (GDP).
During the year, prescription drug spend increased by 5.7
percent to US$ 369.7 billion. In comparison, Medicare spend grew 6.7
percent to US$ 799.4 billion.
President
Joe Biden recently stressed on the need to cap the prices of essential drugs,
and said that the average American pays the highest prices for prescription
drugs anywhere in the world. Americans pay 10 times as much as other countries for life-saving insulin — the top selling prescription drug covered by the Part D program.
Pharma
companies, on the other hand, have vehemently argued against any price cuts in
the US, saying price cuts would hinder drug research and development for all
diseases.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Patented drugs account for 80.3 percent of total Part D spend
Medicare is the US federal government’s program that
provides health insurance to most people who are 65 years
or older. Medicare’s Part D plan provides outpatient drug coverage through private
insurance companies that have contracts with the federal government. Eligible
people have to choose and enroll in a private prescription drug plan for Part D
coverage. Medicare Part B, on the other hand, covers a wide variety of
medically necessary outpatient services and some preventative services.
Prescription
drug coverage under Part D reached US$ 183 billion in 2019 — a growth of around 9 percent over 2018, when spending was US$ 168 billion. Spending
on patented drugs in 2019 accounted for around US$ 147 billion or 80.3 percent
of the total spend for the year. Generic drugs made up for the remaining 19.7
percent (approximately US$ 36 billion). In 2018, generic drugs worth US$ 35.8
billion were sold under Part D, accounting for 21 percent of the total spend
under the program.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Eliquis ranks highest on Medicare’s brand drug spend
Under Part
D, endocrinology and oncology were the two therapeutic areas that generated
maximum revenue for pharma companies, driving home sales of over US$ 31.8
billion and US$ 23.5 billion, respectively. Neurology drugs generated sales of
around US$ 22.9 billion.
Among branded
drugs, Bristol Myers Squibb’s anticoagulant Eliquis (apixaban) was the most selling drug in 2019 under Part D, notching up about US$ 7.3 billion in sales — a rise of US$ 2.3 billion or 46 percent over 2018.
Celgene’s cancer drug Revlimid (lenalidomide) roped in US$ 4.7 billion (up
by 14.6 percent), while another anticoagulant drug Xarelto (rivaroxaban) by Janssen Pharma — a unit of Johnson & Johnson — fetched US$ 4.1 billion (up 20.6 percent) in sales through Part D. AbbVie’s anti-rheumatic drug Humira and Sanofi’s diabetes drug Lantus saw sales of around US$ 3.7 billion each
under the program.
Amongst
generics, the largest selling drug under Part D (by dosage units) was metformin (diabetes), followed by gabapentin (seizure), PEG3350 with
electrolyte (gastroenterology), metoprolol (hypertension) and atorvastatin (cholesterol). In 2019, the
overall dosage units sold also jumped higher by 2.25 billion units to 111.35
billion.
The sales
ranking of Part D does bare some similarities with the global ranking of
highest selling drugs. In 2020, Humira had retained its position as the highest
selling drug in the world, generating sales of US$ 20.4 billion. Both
Eliquis and Revlimid had retained their ranking as the third and fourth most
selling drugs, bringing home US$ 14.1 billion and US$ 12.1 billion in global
sales in 2020.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Medicare’s inability to negotiate prices costs American taxpayers billions of dollars
Over the
years, drug companies have used Medicare’s
inability to negotiate prices under Part D to increase the prices of their
drugs significantly and rip off huge profits, a three-year-long US House
Oversight Committee investigation has revealed.
US taxpayers could have saved over US$ 25 billion in five years if the prices of just seven drugs — Humira, Imbruvica, Sensipar, Enbrel, Lantus, NovoLog and Lyrica — were negotiated by Medicare. Another US$ 16.7 billion could have been saved between
2011 and 2017 on insulin products manufactured by Eli Lilly, Novo Nordisk and Sanofi, which control 90 percent of the insulin market in the US, the committee’s report revealed.
Elsewhere in
the world, the same drugmakers are bending over backwards to get into medical
insurance programs. For instance, China reported that several international
pharma firms, many of them headquartered in the US, slashed the prices of their
drugs by up to 94 percent to get into the country’s national medical insurance coverage.
In the US — which accounted for around 46 percent of the global share of drugs in 2020 — senior citizens may have to pay more for medicines as the government announced a large hike in Medicare premiums for 2022
if an expensive Alzheimer’s drug, Aduhelm, is included in the list.
In order to
ensure inclusion in Medicare, Biogen slashed the price of Aduhelm by half — from US$ 56,000 to US$ 28,200 — just weeks before a crucial meeting called by the CMS. Clearly, this has set a precedent in an industry which is known for rampant price hikes and rarely for any price cuts. This could also be put forth as an example of what Medicare could achieve if it receives negotiation rights.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Our view
President
Biden's Build Back Better legislation,
which the House passed last month, is up for vote in the Senate. The
legislation contains provisions that would allow Medicare to negotiate the
prices of some expensive drugs, penalize drugmakers who raise prices faster
than inflation and cap out-of-pocket costs for insulin at US$ 35 per month.
However, chances of the bill being passed in its present form are slim.
Even if the
Senate passes the bill, Medicare would be able to negotiate the prices of only 10 prescription drugs and insulin products in 2025.
The number would increase over the years, reaching 100 in six years, and hence
forth grow by 20 drugs a year.
It seems like 2022 won’t be the last year when January 1 will be braced with price hikes in the US by drugmakers. Looks like they will continue to make hay while the sun shines.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Impressions: 2621
https://www.pharmacompass.com/radio-compass-blog/america-s-drug-price-hike-conundrum-in-backdrop-of-2019-medicare-part-d-data
#PharmaFlow by PHARMACOMPASS
06 Jan 2022
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Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring
New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on
January 3, 2019. After factoring
in debt, the deal value ballooned to about US$ 95 billion, which according
to data compiled by Refinitiv, made it the largest healthcare deal on
record.
In the summer, AbbVie Inc,
which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic
treatments, for US$ 63 billion. While the companies are still awaiting
regulatory approval for their deal, with US$ 49 billion in combined 2019
revenues, the merged entity would rank amongst the biggest in the industry.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
The big five by pharmaceutical sales — Pfizer,
Roche, J&J, Novartis and Merck
Pfizer
continued
to lead companies by pharmaceutical sales by reporting annual 2019 revenues of
US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to
2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019,
which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in
2019.
In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches.
Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with
Mylan, there weren’t any other big ticket deals which were announced.
The
Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020
revenues between US$ 19 and US$ 20 billion
and could outpace Teva to
become the largest generic company in the world, in term of revenues.
Novartis, which had
followed Pfizer with the second largest revenues in the pharmaceutical industry
in 2018, reported its first full year earnings after spinning off its Alcon eye
care devices business division that
had US$ 7.15 billion in 2018 sales.
In 2019,
Novartis slipped two spots in the ranking after reporting total sales of US$
47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New
Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7
billion to acquire a late-stage cholesterol-lowering
therapy named inclisiran.
As Takeda Pharmaceutical Co was
busy in 2019 on working to reduce its debt burden incurred due to its US$ 62
billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased
the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion.
Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the
gene-therapy maker Novartis had acquired for US$ 8.7 billion.
The deal gave Novartis rights to Zolgensma,
a novel treatment intended for children less than two years of age with the
most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million,
Zolgensma is currently the world’s most expensive drug.
However,
in a shocking announcement, a month after approving the drug, the US Food and
Drug Administration (FDA) issued a press release on
data accuracy issues as the agency was informed by AveXis that
its personnel had manipulated data which
the FDA used to evaluate product comparability and nonclinical (animal)
pharmacology as part of the biologics license application (BLA), which was
submitted and reviewed by the FDA.
With US$
50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker
Roche came in at number two position in 2019
as its sales grew 11 percent driven by
its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta.
Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin.
In late 2019, after months of increased
antitrust scrutiny, Roche completed
its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in
gene therapy.
Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.
Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list.
While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga.
US-headquartered Merck, which is known as
MSD (short for Merck Sharp & Dohme) outside the United States and
Canada, is set to significantly move up the rankings next year fueled by its
cancer drug Keytruda, which witnessed a 55
percent increase in sales to US$ 11.1 billion.
Merck reported total revenues of US$ 41.75 billion and also
announced it will spin off its women’s health drugs,
biosimilar drugs and older products to create a new pharmaceutical
company with US$ 6.5 billion in annual revenues.
The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Humira holds on to remain world’s best-selling drug
AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for
the company. AbbVie has failed to successfully acquire or develop a major new
product to replace the sales generated by its flagship drug.
In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due
to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion.
Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position
and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018.
While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9
billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda.
Keytruda took the number three spot in drug sales that
previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion.
Cancer treatment Imbruvica, which is marketed
by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1
billion in 2019 revenues, it took the number five position.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Vaccines – Covid-19 turns competitors into partners
This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.
GSK reported the highest vaccine sales of all drugmakers with
total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its
total sales of US$ 41.8 billion (GBP 33.754 billion).
US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo.
This is the first FDA-authorized vaccine against the deadly virus which causes
hemorrhagic fever and spreads from person to person through direct contact with
body fluids.
Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4
billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently
pushed drugmakers to move faster than ever before and has also converted
competitors into partners.
In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus.
The two companies plan to start human trials
in the second half of this year, and if things go right, they will file
for potential approvals by the second half of 2021.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Our view
Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.
Our compilation shows that vaccines and drugs
for infectious diseases currently form a tiny fraction of the total sales of
pharmaceutical companies and few drugs against infectious diseases rank high on
the sales list.
This could well explain the limited range of
options currently available to fight Covid-19. With the pandemic currently infecting
over 3 million people spread across more than 200 countries, we can safely
conclude that the scenario in 2020 will change substantially. And so should our
compilation of top drugs for the year.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Impressions: 54745
https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues
#PharmaFlow by PHARMACOMPASS
29 Apr 2020
With almost 30,000 Drug Master Files (DMFs) submitted to the
FDA, reviewing the filings of only the first quarter of 2015, provides an
indicator on the current areas of focus of generic pharmaceutical companies. A
detailed evaluation of the 241 filings for active pharmaceutical ingredients only,
made us find some interesting trends worth sharing.
European Blockbuster
battle!
Of the 241 DMFs, 21 APIs had more than one DMF filing and
accounted for 25% of the total filings. Interestingly, 20 DMFs were for only three APIs:
AstraZeneca’s blood thinner Brilinta® (Ticagrelor), with 2014 sales of $476
million, already had DMF filings from Dr. Reddy’s, Mylan,
Polpharma and
Zhejiang Hisun at the end of last year. With a maximum of 9 new filings from players
like Teva,
Alembic, Lek and
others, AstraZeneca
should brace itself for some serious generic onslaught.
While the 9 filings for Ticagrelor were the most for any
single compound, not far behind is Bayer’s own blood thinner: Xarelto® (Rivaroxaban). With 7 submissions, the
focus of the generic companies is understandable as Rivaroxaban had sales in
excess of $3 billion and year-on-year growth in excess of 70%. However, patents
currently protect the product till 2020, so patience is needed before generics can
access this golden opportunity.
Interestingly, 4 filings for Linagliptin (Boehringer’s antidiabetic Tradjenta®) make it yet another European pharma giant lead the list of products being subjected to generic competition, and make us wonder why European blockbusters are preferred over others?
Exclusive but not
patented
There are products, which have no patent protection, but the
market is protected by FDA granted exclusivities (learn more on patents
and exclusivities from the FDA website).
An opportunity for generic companies to gain significant
market share of a multi-hundred million dollar market, without any litigation
risk or cost is something companies dream about.
As the time of exclusivity expiry nears, Clobazam, Tetrabenazine,
Hydroxyprogesterone Caproate, Deferiprone
and Trypan Blue
will all see increased generic activity as their Drug Master Files have been
submitted.
Fragmented Activity
More than 80% of the DMF submissions were made by companies
who filed only a single product. While the products varied from simple compounds
like Sodium Chloride to biologics like Plasmid DNA, over 140 companies filed DMFs in
the first quarter with almost 30 submitting a DMF for the first time.
An expanding list of suppliers who support DMFs increases
options for sourcing managers. However,
a fragmented supplier base limits the industrial scale companies can achieve and
raises concerns regarding how many can successfully sustain compliance standards
under increased regulatory scrutiny?
The Next Generic Wave
Blood thinners are an opportunity few generic companies wish to pass on. Boehringer’s (Dabigatran Etexilate), Bristol-Myers Squibb’s (Apixaban) and Bayer’s (Rivaroxaban) are novel compounds in this category which had combined sales in excess of $5 billion last year.
While Dagibatran saw a flurry of activity over the last two
years with almost 15 DMF filings, there were no additional filings this year.
On the other hand, Apixaban, which generated $774 million
for Bristol-Myers Squibb in 2014, has only one DMF filing at the moment and that too was done
over a year ago. The export data out of India, reviewed on PharmaCompass, for
Apixaban, indicates that product development is already complete so it is just
a matter of time before the filings begin.
Conclusion:
Product and supplier selection is a critical component of every generic company’s strategy. The PharmaCompass database is designed to assist professionals in business development, marketing and sourcing to take more informed decisions.
If you would like us to share our shortlist of 241 DMFs, we will be happy to send it to you by email (click here). You can also access our compilation of the 2014 annual reports of
major pharmaceutical companies to review the various products along with their
revenues (click here):
Table: Products with more than one DMF filing in Q1 2015
PRODUCT NAME
DMF FILINGS
TICAGRELOR
9
RIVAROXABAN
7
LINAGLIPTIN
4
APREPITANT
3
CINACALCET HYDROCHLORIDE
3
ATAZANAVIR SULFATE
2
ATORVASTATIN CALCIUM TRIHYDRATE
2
CLOBAZAM
2
CLOFARABINE
2
DEFERASIROX
2
DIMETHYL FUMARATE
2
EZETIMIBE
2
ICATIBANT ACETATE
2
LURASIDONE HYDROCHLORIDE
2
MELPHALAN HYDROCHLORIDE
2
OLANZAPINE
2
OLMESARTAN MEDOXOMIL USP
2
PRASUGREL HYDROCHLORIDE
2
RIVASTIGMINE USP
2
ROSUVASTATIN CALCIUM
2
SOLIFENACINE SUCCINATE
2
Impressions: 8781
https://www.pharmacompass.com/radio-compass-blog/the-next-generic-attack-brilinta-ticagrelor-xarelto-rivaroxaban-tradjenta-linagliptin-and
#PharmaFlow by PHARMACOMPASS
13 May 2015
