Sanofi-Aventis Korea has finally launched its atopic dermatitis therapy Dupixent (dupilumab) on the market, raising the question of how many people would be able to afford it.
Dupixent is the first targeted biologic to be used in adults who have moderate-to-severe atopic dermatitis. The Ministry of Food and Drug Safety approved the drug in March and gave the drug’s marketing approval to the company earlier this month.
Although Sanofi Korea officials declined to comment on the price in Korea, a two 2-ml syringe pack is listed at £1,264.89 in the U.K. and carries an annual list price of $37,000 in the United States.
Due to concerns about cost-effectiveness, the French pharmaceutical company earlier this month faced a rejection from the National Institute for Health and Care Excellence (NICE), which did not recommend Dupixent for patients with the condition.
“Dupilumab is not recommended, within its marketing authorization, for treating moderate to severe atopic dermatitis in adults when systemic therapy is suitable,” the committee wrote. “Dupilumab does not reflect the good use of limited NHS resources.”
Regarding the NICE’s decision, Marcus Martin Klein, regional medical head of the JPAC region for Sanofi Genzyme, said the firm would reapply for the regulatory body’s backing in the U.K.
“It is not unusual to negotiate and go into another round with NICE,” Klein said. “We believe that the treatment helps [atopic dermatitis patients] so we will apply once more.”
Too many atopic dermatitis patients, too heavy a burden
A Sanofi-Aventis Korea official said the Korean branch is “actively” submitting papers for reimbursement to lower the cost of the therapy for patients in need.
But the official cautiously noted that while Korean data differs from that of the United Kingdom, “the environment and circumstances are very similar.”
Experts also noted that getting coverage for Dupixent will be an uphill battle.
“It’s not possible because the prevalence of atopic dermatitis is so high. If government insurance covers this medication, national funds will decrease,” said an industry insider who claimed anonymity. “This is especially true if everyone wants to get treated with Dupixent.”
Government data estimates up to 360,000 Korean adults suffer from the chronic inflammatory disease characterized by skin rashes that cause intense, persistent itching and skin dryness, cracking redness, crusting, and oozing.
The official pointed out that in most cases, patients who have severe atopic dermatitis symptoms will spend lots of money to relieve them. If they don’t have money, however, they have no relief.
“This is a big problem for both the patient and the government,” he said. “I also think Dupixent will most likely not get reimbursement because insurance does not cover similar medications for psoriasis.”
The official noted that although medications for general psoriasis are not covered, those for psoriasis arthritis and severe psoriasis are, indicating that Dupixent may also get approval if it narrows its indications to a small population.
Reimbursement a distant hope
Getting treated with Dupixent at an affordable price is not a reality, leaving the expensive therapy out of reach for many. An online petition made to the Blue House received more than 3,100 signatures as of Thursday.
“I thought that I would now be able to get appropriate treatment having lived in continual suffering. But the fact that the price is over 40 million won ($36,950) is like saying I should keep suffering even though a therapy exists,” the petition read.
Despite patients’ cries for lowered drug prices, Sanofi Korea officials said that many would still use Dupixent because an urgent need exists.
“Immunotherapies are very expensive, and most people cannot afford them, but people are still willing to pay for it because there is a need. So [cost-effectiveness] should be measured by the physician and patients,” the Sanofi official said.