Can­cer bur­den on rise in China

BioSpectrum (Asia) - - Front Page - Narayan Kulka­rni Narayan.kulka­rni@mmac­tiv.com

With rise in can­cer bur­den in China since 2000, to ease the fi­nan­cial bur­den of pa­tients with can­cer and re­duce the price of costly can­cer drugs, the Chi­nese gov­ern­ment has vowed to take im­me­di­ate steps to ex­empt tar­iffs on im­ported can­cer drugs, ini­ti­ate cen­tralised gov­ern­ment ne­go­ti­a­tions and pro­cure­ment of can­cer drugs, and in­cor­po­rate more can­cer drugs into the cat­a­logue of med­i­cal in­sur­ance re­im­burse­ment. China has also reached an agree­ment with In­dia on re­duc­tion of tar­iffs on the im­port of In­dian medicines, par­tic­u­larly can­cer drugs.

Can­cer is a ma­jor pub­lic health con­cern in China. Ac­cord­ing to the Na­tional Cen­tral Can­cer Reg­istry of China, there were around 4•3 mil­lion new can­cer cases and 2•8 mil­lion can­cer deaths in China in 2015. In 2014, there were about 3.8 mil­lion new can­cer cases and 2.3 mil­lion can­cer deaths in China. The age-stan­dard­ized can­cer in­ci­dence and mor­tal­ity rates were 190.63/100,000 and 106.98/100,000, re­spec­tively. The over­all can­cer bur­den in China has been in­creas­ing since 2000.

“Lung can­cer is a ma­jor pub­lic health is­sue in China, rep­re­sent­ing the high­est in­ci­dence and mor­tal­ity among all can­cers in the coun­try,” says Pro­fes­sor Yi-Long Wu, a tenured direc­tor of Guang­dong Gen­eral Hos­pi­tal and the chair of the Chi­nese Tho­racic On­col­ogy Group.

There are ap­prox­i­mately 781,000 new cases of lung can­cer di­ag­nosed in China each year, equalling ap­prox­i­mately 15 new cases ev­ery 10 min­utes. This num­ber con­tin­ues to rise, with more than 800,000 new cases and 700,000 new deaths pro­jected by 2020. Sur­vival rates vary depend­ing on the stage and type of the can­cer when di­ag­nosed, with the five-year sur­vival rate lower than 5 per cent. For pa­tients with ad­vanced squa­mous cell lung can­cer and non-squa­mous non-small cell lung can­cer (NSCLC) with­out any known driver ge­netic mu­ta­tion, treat­ment mea­sures are quite limited. There­fore, long-term sur­vival is the most ur­gent need of those pa­tients.

Chi­nese gov­ern­ment has taken up many steps to sup­port the pa­tient pop­u­la­tion.

Some of the ini­tia­tives in­clude for­ma­tion of a com­pre­hen­sive net­work on can­cer preven­tion and con­trol; build­ing up a na­tion­wide pop­u­la­tion-based

can­cer surveil­lance; ex­pand­ing the pop­u­la­tion cover­age of can­cer surveil­lance, and im­prov­ing the data qual­ity. With an in­crease in ag­ing pop­u­la­tion and per­sis­tence of un­healthy life styles among Chi­nese, there will be an un­avoid­able can­cer bur­den in China.

To meet the re­quire­ments of can­cer pa­tients, the China Food and Drug Ad­min­is­tra­tion on June 15, has given ap­proval to Bris­tol My­ers Squibb’s Op­divo (nivolumab in­jec­tion) for the treat­ment of lo­cally ad­vanced or metastatic non-small cell lung can­cer (NSCLC) af­ter prior plat­inum-based chemo­ther­apy in adult pa­tients with­out EGFR or ALK ge­nomic tu­mor aber­ra­tions.

This is China’s first and only PD-1 in­hibitor and is the only Im­muno-On­col­ogy (I-O) agent to demon­strate a sur­vival ben­e­fit com­pared with chemo­ther­apy, based on data from the piv­otal Phase 3 Check­Mate -078 trial, in which 90 per cent of the pa­tients en­rolled were Chi­nese.

The com­pany noted that the ap­proval is based on re­sults from the Phase 3 Check­Mate -078 trial of Op­divo ver­sus chemo­ther­apy among pa­tients with pre­vi­ously treated NSCLC, find­ings from which were pre­sented at the Amer­i­can As­so­ci­a­tion for Can­cer Re­search An­nual Meet­ing in April 2018. In Novem­ber 2017, the trial was stopped early be­cause the in­de­pen­dent Data Mon­i­tor­ing Com­mit­tee con­cluded that Op­divo demon­strated su­pe­rior over­all sur­vival com­pared with chemo­ther­apy. The ap­pli­ca­tion later re­ceived pri­or­ity re­view by the Cen­tre for Drug Eval­u­a­tion in China.

Bris­tol My­ers Squibb fur­ther pointed out in a re­lease that in Check­Mate -078, Op­divo re­duced the risk of death by 32 per cent ver­sus chemo­ther­apy, the pri­mary end­point (HR 0.68; 97.7% CI: 0.52 to 0.90; p=0.0006), in pa­tients with pre­vi­ously treated NSCLC. Both ef­fi­cacy and safety of Op­divo in this pa­tient pop­u­la­tion were con­sis­tent with the re­sults of the land­mark global Check­Mate -017 and -057 stud­ies. In Check­Mate -078, Grade 3-4 treat­ment-re­lated ad­verse events (TRAEs) oc­curred less fre­quently with Op­divo ver­sus do­c­etaxel (10% vs. 48%). Dis­con­tin­u­a­tions due to Grade 3-4 TRAEs were also less fre­quent with Op­divo (3%) than with do­c­etaxel (5%).

Murdo Gor­don, ex­ec­u­tive vice pres­i­dent and chief com­mer­cial of­fi­cer, Bris­tol-My­ers Squibb, shared, “With ap­provals in more than 60 coun­tries, Op­divo is a global stan­dard of care for pre­vi­ously treated

NSCLC, and we are proud to bring this foun­da­tional I-O treat­ment op­tion to pa­tients and physi­cians in China. We look for­ward to con­tin­u­ing to work to­gether with the CNDA to usher in ad­di­tional health­care in­no­va­tions in China, with our shared com­mit­ment to mov­ing quickly to help pa­tients.”

Pro­fes­sor Yi-Long Wu, a tenured direc­tor of Guang­dong Gen­eral Hos­pi­tal and the chair of the Chi­nese Tho­racic On­col­ogy Group said, “With most lung can­cer pa­tients al­ready at an ad­vanced stage when di­ag­nosed, pro­long­ing sur­vival is an im­por­tant goal. The ap­proval of Op­divo as the first I-O agent in China is a sig­nif­i­cant ther­a­peu­tic ad­vance and is great news for pa­tients and clin­i­cians alike, of­fer­ing for the first time an I-O treat­ment op­tion that is proven to ex­tend sur­vival in pre­dom­i­nantly Chi­nese pa­tients with pre­vi­ously treated NSCLC.”

“We are thrilled to be able to bring this proven treat­ment, Op­divo, which has demon­strated su­pe­rior over­all sur­vival ver­sus chemo­ther­apy in pre­vi­ously treated NSCLC pa­tients in China, and are com­mit­ted to work­ing with stake­hold­ers to en­sure pa­tients can quickly ac­cess Op­divo,” said Fouad Namouni, M.D., head of de­vel­op­ment, On­col­ogy, Bris­tol-My­ers Squibb. “With more than 7,500 can­cer deaths per day es­ti­mated in China, we will con­tinue to work with ur­gency to in­te­grate the un­met treat­ment needs of Chi­nese pa­tients in our on­go­ing I-O global de­vel­op­ment pro­gram, with the goal of bring­ing them in­no­va­tive ther­a­pies as quickly as pos­si­ble.”

Im­prov­ing ac­ces­si­bil­ity and avail­abil­ity

Ac­cord­ing to The Lancet re­port pub­lished on May 12, 2018 ti­tled ‘Can­cer drugs in China: af­ford­abil­ity and cre­ativ­ity’, “Im­prov­ing the ac­ces­si­bil­ity and avail­abil­ity of ef­fec­tive treat­ments is key to tack­ling the huge bur­den of can­cer in China. How­ever, in terms of lo­cal af­ford­abil­ity of can­cer drugs, China emerges as one of the coun­tries with the least af­ford­able prices in the world.”

The re­port notes that to ease the fi­nan­cial bur­den of pa­tients with can­cer and re­duce the price of costly can­cer drugs, the Chi­nese gov­ern­ment has vowed to take im­me­di­ate steps to ex­empt tar­iffs on im­ported can­cer drugs as of May 1, ini­ti­ate cen­tralised gov­ern­ment ne­go­ti­a­tions and pro­cure­ment of can­cer drugs, and in­cor­po­rate more can­cer drugs into the cat­a­logue of med­i­cal in­sur­ance re­im­burse­ment. Fur­ther­more, as the vice direc­tor of the Na­tional Health Com­mis­sion Zeng Yixin pointed

out, a long-term strat­egy of con­trol­ling can­cer drug pric­ing fur­ther will be built up through four ma­jor ar­eas: en­cour­ag­ing new can­cer drug dis­cov­ery and de­vel­op­ment, ac­cel­er­at­ing the re­view and ap­proval pro­ce­dures for new medicines, re­duc­ing cir­cu­la­tion costs, and im­prov­ing can­cer di­ag­no­sis and ra­tio­nal drug use in China.

Can­cer care re­mains a mas­sive bur­den on China's health sys­tem. The sales of an­ti­cancer medicines in China ex­ceed 120 bil­lion yuan ($19•12 bil­lion) per year, half of which are gen­er­ated by im­ported medicines that China heav­ily re­lies on.

The Lancet con­tin­ues to add that un­der­stand­ably, there is con­cern that the tar­iff cut could put some pres­sure on do­mes­tic phar­ma­ceu­ti­cal com­pa­nies due to more tense competition. How­ever, it will be cru­cial to seize the great op­por­tu­nity of China's longterm plan of greater in­vest­ment in drug dis­cov­ery, to strengthen China's own vi­brant and in­no­va­tive phar­ma­ceu­ti­cal in­dus­try, in col­lab­o­ra­tion with dif­fer­ent stake­hold­ers, par­tic­u­larly academia, and to de­velop af­ford­able and ef­fec­tive medicines for pa­tients in China. Even with­out tar­iffs, the price of im­ported drugs is still likely to be un­sus­tain­able (as else­where in the world) with­out lo­cal Chi­nese so­lu­tions.

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