Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News
Amid Talk of Curbing Prices, Most Treatments Show Sales Gains
Even as drug costs remain sky-high enough to anger American patients, several recent developments suggest that key stakeholders may finally be getting the message to do something about them, or at least look like they’re doing something.
The most recent such development (at deadline) came March 6, when UnitedHealthcare announced it will expand pharmacy discounts to more than 7 million people enrolled in its insured commercial group benefit plans. When the policy is implemented starting next year, the insurer says, consumers will see lower out-of-pocket costs as the insurer shares with them savings from pharmacy manufacturer rebates at the time of purchase.
UnitedHealthcare’s announcement brought the insurer praise from Health and Human Services Secretary Alex Azar. A week earlier, he highlighted proposals to lower drug prices that were contained in both a white paper by the presidential Council of Economic Advisers and included in the $4.4 trillion budget proposed by President Donald Trump for the 2019 federal fiscal year, which starts October 1. One proposal would require insurers and pharmacy benefit managers to share with Part D Medicaid enrollees more of the discounts they receive from drug manufacturers and would allow insurers to cover just one drug per category instead of two. Other proposals would allow up to five states to determine what drugs could be covered, cap out-of-pocket spending for Medicare enrollees, and accelerate development of generic drugs.
Drug spending in the U.S. is projected to reach $590 billion by 2020, up from $337 billion in 2015, according to insurance industry group America’s Health Insurance Programs (AHIP). Increased sharing of discounts and other actions aimed at lowering prices will reduce profits for Biopharmas, as well as shrink how much they ultimately generate in sales from their therapies.
Below is GEN’s updated top 15 list of top-selling prescription drugs. The top-selling drug on last year’s list was the same one that topped GEN’s first list of best-selling drugs in 2013, when it generated $10.659 billion—which means that its sales have nearly doubled, rocketing almost 73%, in the past five years.
Nine of last year’s 15 top-selling drugs saw year-over-year sales gains, with five of the nine registering double-digit increases (and a sixth coming close at 9.4%). The rest of the list saw sales declines since 2016, most often reflecting the launch of generic competitors or insurer discounts.
Two drugs are new to the best-seller list this year: The Bristol-Myers Squibb (BMS)/Pfizer anticoagulant Eliquis® (apixaban) could be ranked for 2017 since unlike the previous year, Pfizer included Eliquis-specific figures in its fourth-quarter results. BMS has another newcomer to the list, the cancer immunotherapy Opdivo® (nivollumab), which outsold its rival Keytruda® (pembrolizumab)—though the Merck & Co. immuno-oncology treatment could appear in future years since it finished No. 21 with $3.809 billion, more than double its 2016 sales (171.6%).
Just shy of the top 15, ranking #20 through #16, are treatments that all generated between $3.9 billion and $4.4 billion last year—Novo Nordisk’s Victoza® (liraglutide), Johnson & Johnson’s Stelara® (ustekinumab), Biogen’s Tecfidera® (dimethyl fumarate), GlaxoSmithKline’s Advair® / Seretide® (fluticasone and salmeterol), and Gilead Sciences’ Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg).
Among top disease categories, cancer remains on top with six of the 15 top sellers—including three of the top five. Arthritis accounts for four of the top 15, all within the top half of the list, while Crohn’s disease is included among indications for two of the top sellers, and diabetes, just one. Unlike recent years, none of the top 15 drugs are indicated for hepatitis, with Harvoni missing the top 15 following discounts to insurers.
Top-selling drugs are ranked based on sales or revenue reported for 2017 by biopharma companies in press announcements, annual reports, investor materials, and/or conference calls. Each drug is listed by name, sponsor(s), diseases indicated, 2017 sales, 2016 sales, and the percentage change between both years.
#15. Neulasta® / Peglasta® (pegfilgrastim)
Sponsor(s): Amgen and Kyowa Hakko Kirin1
Indication(s): Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia; and increasing survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome or acute radiation syndrome)
2017 sales: $4.723 billion ($4.534 billion Amgen + $0.189 billion [¥20.1 billion] Kyowa Hakko Kirin 2
2016 sales: $4.808 billion ($4.648 billion Amgen + $0.160 billion [¥17.0 billion] Kyowa Hakko Kirin 2
% Change: -1.8%
#14. Opdivo® (generic name)
Sponsor(s): Bristol-Myers Squibb
Indication(s): BRAF V600 wild-type unresectable or metastatic melanoma; BRAF V600 mutation-positive unresectable or metastatic melanoma; unresectable or metastatic melanoma, in combination with ipilimumab; melanoma with lymph node involvement or metastatic disease in patients who have undergone complete resection, in the adjuvant setting; metastatic non-small cell lung cancer (NSCLC) and progression on or after platinum-based chemotherapy; advanced renal cell carcinoma in patients who have received prior antiangiogenic therapy; classical Hodgkin lymphoma that has relapsed or progressed in adults after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or three or more lines of systemic therapy that includes autologous HSCT; recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy; locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan in patients 12 years and older; hepatocellular carcinoma in patients previously treated with sorafenib
2017 sales: $4.948 billion
2016 sales: $3.774 billion
% Change: 31.1%
#13. Lyrica® (pregabaliln)
Sponsor(s): Pfizer
Indication(s): Neuropathic pain associated with diabetic peripheral neuropathy (DPN); Postherpetic neuralgia (PHN); Adjunctive therapy for adult patients with partial onset seizures; Fibromyalgia; Neuropathic pain associated with spinal cord injury
2017 sales: $5.065 billion3
2016 sales: $4.966 billion3
% Change: 2.0%
#12. Prevnar 13® / Prevenar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])
Sponsor(s): Pfizer
Indication(s): Prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in adults aged 18 and older; prevention of invasive disease caused by the 13 serotypes in children ages 6–17; prevention of invasive disease caused by the 13 serotypes in children ages 6 weeks through 5 years old; prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in children ages 6 weeks through 5 years old
2017 sales: $5.601 billion
2016 sales: $5.718 billion
% Change: -2.0%
#11. Lantus® (insulin glargine)
Sponsor(s): Sanofi
Indication(s): Once-daily treatment for improving glycemic control in adults and pediatric patients with type 1 diabetes, and in adults with type 2 diabetes
2017 sales: $5.732 billion (€4.622 billion)
2016 sales: $7.086 billion (€5.714 billion)
% Change: -19.1%
#10. Eylea® (aflibercept)
Sponsor(s): Bayer and Regeneron Pharmaceuticals
Indication(s): Neovascular (wet) age-related macular degeneration; macular edema following retinal vein occlusion; diabetic macular edema (DME); diabetic retinopathy in patients with DME
2017 sales: $6.034 billion ($2.332 billion [€1.880 billion Bayer + $3.702 billion Regeneron)
2016 sales: $5.338 billion ($2.015 billion [€1.625 billion Bayer + $3.323 billion Regeneron)
% Change: 9.4%
#9. Xarelto® (rivaroxaban)
Sponsor(s): Bayer and Johnson & Johnson
Indication(s): Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; deep vein thrombosis (DVT) and pulmonary embolism (PE), and reduction in the risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least six months; prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery
2017 sales: $6.589 billion ($4.089 billion [€3.298 billion] Bayer + $2.500 billion J&J)
2016 sales: $5.919 billion ($3.631 billion [€2.928 billion] Bayer + $2.288 billion J&J)
% Change: 11.3%
#8. Avastin® (generic name)
Sponsor(s): Roche (Genentech)
Indication(s): Metastatic colorectal cancer with intravenous 5-fluorouracil–based chemotherapy for first-or second-line treatment; metastatic colorectal cancer, with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line Avastin-containing regimen; nonsquamous non-small cell lung cancer, with carboplatin and paclitaxel for first-line treatment of unresectable, locally advanced, recurrent or metastatic disease; glioblastoma, as a single agent for adult patients with progressive disease following prior therapy; metastatic renal cell carcinoma with interferon alfa; cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan in persistent, recurrent, or metastatic disease; recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer that is either platinum-resistant, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, or platinum-sensitive, in combination with carboplatin and paclitaxel, or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent
2017 sales: $7.096 billion (CHF 6.688 billion)
2016 sales: $7.197 billion (CHF 6.783 billion]
% Change: -1.4%
#7. Remicade® (infliximab)
Sponsor(s): Johnson & Johnson and Merck & Co.
Indication(s): Moderately to severely active Crohn's disease in adults and children who have had an inadequate response to conventional therapy; reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adults with fistulizing disease; moderately to severely active ulcerative colitis in adults and children who have had an inadequate response to conventional therapy; moderately to severely active rheumatoid arthritis in adults (with methotrexate); moderate to severely active rheumatoid arthritis; active ankylosing spondylitis; active psoriatic arthritis; chronic, severe (extensive, and/or disabling) plaque psoriasis in adults who are candidates for systemic therapy, and when other systemic therapies are medically less appropriate
2017 sales: $7.152 billion ($6.315 billion J&J + $0.837 billion Merck)
2016 sales: $8.234 billion ($6.966 billion J&J + $1.268 billion Merck)
% Change: -13.1%
#6. Eliquis® (generic name)
Sponsor(s): Bristol-Myers Squibb and Pfizer4
Indication(s): Risk reduction of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; DVT and PE treatment; risk reduction of recurrent DVT and PE following initial therapy
2017 sales: $7.395 billion ($4.872 billion Bristol-Myers Squibb + $2.523 billion Pfizer)
2016 sales: $5.056 billion ($3.343 billion Bristol-Myers Squibb + $1.713 billion Pfizer)
% Change: 46.3%
#5. Herceptin® (generic name)
Sponsor(s): Roche (Genentech)
Indication(s): HER2 overexpressing breast cancer; HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma
2017 sales: $7.441 billion (CHF 7.014 billion)
2016 sales: $7.195 billion (CHF 6.782 billion]
% Change: 3.4%
#4. Enbrel® (etanercept)
Sponsor(s): Amgen and Pfizer5
Indication(s): Rheumatoid arthritis; polyarticular juvenile idiopathic arthritis in patients aged 2 years or older; psoriatic arthritis; ankylosing spondylitis; plaque psoriasis in patients aged 4 years or older
2017 sales: $7.885 billion ($5.433 billion Amgen + $2.452 billion Pfizer)
2016 sales: $8.874 billion ($5.965 billion Amgen + $2.909 billion Pfizer)
% Change: -11.1%
#3. Revlimid® (lenalidomide)
Sponsor(s): Celgene
Indication(s): Multiple myeloma, in combination with dexamethasone; multiple myeloma, as a maintenance therapy following autologous hematopoietic stem cell transplantation; transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities; mantle cell lymphoma in patients whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
2017 sales: $8.187 billion
2016 sales: $6.974 billion
% Change: 17.4%
#2. Rituxan® (also sold as MabThera; rituximab)
Sponsor(s): Roche (Genentech) and Biogen
Indication(s): Non-Hodgkin’s lymphoma; chronic lymphocytic leukemia; rheumatoid arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely active RA who have inadequate response to one or more TNF-antagonist therapies; granulomatosis with polyangiitis (GPA) (Wegener’s granulomatosis) and microscopic polyangiitis (MPA) in adults in combination with glucocorticoids
2017 sales: $9.238 billion ($7.838 billion [CHF 7.388 billion] Roche + $1.400 billion Biogen)
2016 sales: $9.059 billion ($7.744 billion [CHF 7.300 billion] Roche + $1.315 billion Biogen)
% Change: 2.0%
#1. Humira® (adalimumab)
Sponsor(s): AbbVie
Indication(s): Moderate to severely active rheumatoid arthritis (RA); moderate to severely active polyarticular juvenile idiopathic arthritis; active psoriatic arthritis in adults; active ankylosing spondylitis in adults; moderate to severely active Crohn’s disease in adults who have had an inadequate response to conventional therapy; moderate to severely active pediatric Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate; moderate to severely active ulcerative colitis in adults who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP); moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy; moderate to severe hidradenitis suppurativa; non-infectious intermediate, posterior panuveitis in adults.
2017 sales: $18.427 billion
2016 sales: $16.078 billion
% Change: 14.6%
Notes:
1 Effective January 1, 2014, Amgen acquired rights to pegfilgrastim from Roche. Roche had held those rights under license from Kirin-Amgen (a joint venture between Amgen and Kirin Holdings, of Japan), in Eastern Europe, Latin America, Asia, the Middle East, and Africa since 1989. See Amgen announcement of October 22, 2013.
2 Kyowa Hakko Kirin retains rights to pegfilgrastim under the names G-Lasta® in Japan, Peglasta® in Singapore and Thailand, and Neulasta® in Taiwan. Figures for Kyowa Hakko Kirin combine sales of G-Lasta ($0.170 billion [¥18.1 billion] in 2017; $0.146 billion [¥15.5 billion] in 2016) with sales of Neulasta/Peglasta ($0.019 billion [¥2.0 billion in 2017; $0.014 billion [¥1.5 billion] in 2016).
3 Pfizer lists separately the Lyrica revenues generated in all of Europe, Russia, Turkey, Israel, and Central Asia countries ($553 million in 2017, $801 million in 2016). Those revenues are listed by Pfizer’s “Essential Health” operating segment, while its “Innovative Health” segment records Lyrica revenues generated elsewhere in the world, including the U.S. ($4.511 billion in 2017, $4.165 billion in 2016).
4 Pfizer figures for Eliquis consist of “alliance revenues” reflecting products co-developed with partner companies, as well as direct sales in some regions of the world
5 Pfizer markets Enbrel outside the U.S. and Canada, where the treatment is marketed by Amgen.
