ASIA NEEDS A LE­GAL FRAME­WORK TO COM­BAT RARE DIS­EASES

Aus­tralia's way of ad­dress­ing cancer bur­den

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

Cancer con­tin­ues to be the great­est cause of health bur­den in Aus­tralia, ac­count­ing for around one-fifth (19%) of the to­tal dis­ease bur­den in 2011. It is es­ti­mated that 134,174 new cases of cancer will be di­ag­nosed in Aus­tralia in 2017, an av­er­age of 367 di­ag­noses each day. Five-year relative sur­vival from all can­cers com­bined in­creased from 48% in 1984–1988 to 68% in 2009–2013. Ac­cord­ing to World Health Or­ga­ni­za­tion com­par­isons, peo­ple liv­ing in Aus­tralia gen­er­ally had bet­ter cancer sur­vival than those liv­ing in other coun­tries and re­gions.

Cancer, a generic term de­scrib­ing a large group of dis­eases, is among the lead­ing causes of mor­bid­ity and mor­tal­ity world­wide. Aus­tralia has among the high­est in­ci­dence of cancer in the world but it also has one of the world’s best sur­vival out­comes. This is be­cause of its com­pre­hen­sive health care sys­tem which de­liv­ers ac­cess to skilled health pro­fes­sion­als, ef­fec­tive and ap­pro­pri­ate treat­ments, high qual­ity care, af­ford­able medicines and on­go­ing ed­u­ca­tion. In Aus­tralia, over the pe­riod 2009-2013, peo­ple di­ag­nosed with cancer had a 68% chance of sur­viv­ing for at least 5 years, a sig­nif­i­cant im­prove­ment from 48% over the pe­riod 1984-1988.

In De­cem­ber 2014, the Se­nate re­ferred the mat­ter of the avail­abil­ity of new, in­no­va­tive and spe­cial­ist cancer drugs in Aus­tralia to its Com­mu­nity Af­fairs Ref­er­ences Com­mit­tee. The Com­mit­tee re­ported on Septem­ber 17, 2015, not­ing that over 45,000 peo­ple would die from cancer in 2015, rep­re­sent­ing three out of ev­ery 10 deaths reg­is­tered in Aus­tralia. The Com­mit­tee rec­om­mended a com­pre­hen­sive review of Aus­tralia’s medicine regis­tra­tion and re­im­burse­ment sys­tems, a review of cur­rent data col­lec­tion mech­a­nisms for cancer medicines and an ex­am­i­na­tion of the fea­si­bil­ity of es­tab­lish­ing a na­tional reg­is­ter of cancer medicines.

Re­act­ing to the Se­nate Com­mit­tee Re­port, the Aus­tralian govern­ment noted that cur­rently it spends an es­ti­mated $4-5 bil­lion per an­num on the treat­ment of cancer. With an age­ing pop­u­la­tion and the preva­lence of cancer trend­ing up­wards, the health and eco­nomic im­pacts on in­di­vid­u­als and the health sys­tem can be ex­pected to con­tinue to in­crease. A key driver of Aus­tralian govern­ment ex­pen­di­ture is the growth in the number and cost of medicines sub­sidised through the Phar­ma­ceu­ti­cal Ben­e­fits Scheme (PBS) for the treat­ment of cancer.

In 2015-16, the Aus­tralian govern­ment spent over $11 bil­lion on PBS and Repa­tri­a­tion Phar­ma­ceu­ti­cal Ben­e­fits Scheme (RPBS) medicines, of which $1.9 bil­lion was for cancer medicines, that is, around one in ev­ery six dol­lars of PBS ex­pen­di­ture sub­sidises cancer medicines. The av­er­age re­im­burse­ment price for cancer medicines in­creased 133 per cent in real terms from 1999-2000 to 2011-2012. In con­trast, the price

of non-cancer pre­scrip­tion medicines in­creased 37 per cent in the same pe­riod.

There are ap­prox­i­mately 110 cancer medicines avail­able on the PBS. From Oc­to­ber 2013 to Au­gust 2017, the Aus­tralian govern­ment has ap­proved over 60 new cancer medicines (or amended listings) at a to­tal cost to govern­ment (es­ti­mated for the rel­e­vant bud­get pe­riod at the time of each list­ing) of around $4 bil­lion. This in­cludes new treat­ments for ad­vanced pan­cre­atic cancer, melanoma, rare gi­ant cell bone tu­mours, ad­vanced breast cancer, and ovar­ian, fal­lop­ian tube, and pri­mary peri­toneal cancer.

The Aus­tralian govern­ment has also in­vested in cancer pre­ven­tion through suc­cess­ful mea­sures such as im­mu­ni­sa­tion and screen­ing pro­grams. The hu­man pa­pil­lo­mavirus (HPV) vac­cine is pro­vided in schools to all males and fe­males aged 12-13 years through the Na­tional Im­mu­ni­sa­tion Pro­gram (NIP). Free HPV vac­cines have been made avail­able through school based pro­grams for girls since 2007 and boys since 2013. A 2015 in­de­pen­dent eval­u­a­tion of the Aus­tralian HPV Vac­ci­na­tion Pro­gram (con­ducted by the Na­tional Cen­tre for Im­mu­ni­sa­tion Re­search and Sur­veil­lance at the Univer­sity of Syd­ney) found that the Pro­gram had been suc­cess­ful in re­duc­ing the in­ci­dence of cer­vi­cal ab­nor­mal­i­ties in young women and anogen­i­tal warts in men and women. These re­duc­tions are ex­pected to sig­nif­i­cantly re­duce the preva­lence of cer­vi­cal cancer among women. Ac­cord­ing to a re­port “The Bur­den of Cancer in Aus­tralia: Aus­tralian Bur­den of Dis­ease Study 2011” re­leased by the Aus­tralian In­sti­tute of Health and Wel­fare (AIHW) in June last year, cancer con­tin­ues to be the great­est cause of health bur­den in Aus­tralia, ac­count­ing for around one-fifth (19%) of the to­tal dis­ease bur­den in 2011.

The re­port finds that in 2017, it is es­ti­mated that 134,174 new cases of cancer (ex­clud­ing basal and squa­mous cell car­ci­noma of the skin) will be di­ag­nosed in Aus­tralia, an av­er­age of 367 di­ag­noses each day. It is ex­pected that more than half (54%) of these di­ag­nosed cases will be for males and 71% for those aged 60 and over. The age-stan­dard­ised rate of new cancer cases in­creased from 383 per 100,000 per­sons in 1982 to a peak of 504 per 100,000 in 2008, be­fore an ex­pected de­crease to 470 per 100,000 in 2017. The de­crease has mainly been ob­served in males and is strongly in­flu­enced by changes in the in­ci­dence rate of prostate cancer. In 2017, breast cancer in fe­males is ex­pected to be the most com­mon cancer in Aus­tralia, fol­lowed by colorec­tal (bowel) cancer, prostate cancer and melanoma of the skin.

In 2017, it is es­ti­mated that 47,753 peo­ple will die from cancer in Aus­tralia, an av­er­age of 131 deaths each day. It is ex­pected that more than half (57%) of these deaths will be in males and 87% among peo­ple aged 60 and over. Males are es­ti­mated to have a higher age-stan­dard­ised mor­tal­ity rate than fe­males (200 com­pared with 129 per 100,000). It is es­ti­mated that the age-stan­dard­ised mor­tal­ity rate from all can­cers com­bined will de­crease from 209 per 100,000 in 1982 to 161 per 100,000 in 2017. In 2014, cancer ac­counted for about 3 of ev­ery 10 deaths reg­is­tered in Aus­tralia. In 2017, lung cancer is ex­pected to be the lead­ing cause of cancer death, fol­lowed by colorec­tal cancer, prostate cancer, breast cancer in fe­males and pan­cre­atic cancer.

Sur­vival rate improves, but not for all can­cers

Five-year relative sur­vival from all can­cers com­bined in­creased from 48% in 1984–1988 to 68% in 2009– 2013. Can­cers that had the largest in­crease in sur­vival were prostate cancer, non-Hodgkin lym­phoma, kid­ney cancer and mul­ti­ple myeloma. Pan­cre­atic cancer and lung cancer showed only small im­prove­ments; blad­der cancer and cancer of the lar­ynx had a de­crease in sur­vival; and lip cancer and mesothe­lioma had no change. The re­port notes that, ac­cord­ing to World Health Or­ga­ni­za­tion com­par­isons, peo­ple liv­ing in Aus­tralia gen­er­ally had bet­ter cancer sur­vival than those liv­ing in other coun­tries and re­gions.

In 2011, cancer was the lead­ing cause of dis­ease bur­den in Aus­tralia. Aus­tralians lost 833,250 dis­abil­ity-ad­justed life years (DALY) due to pre­ma­ture death from cancer or from liv­ing with cancer (19% of to­tal DALY). Lung cancer was as­so­ci­ated with the high­est pro­por­tion of the cancer bur­den, fol­lowed by colorec­tal cancer, breast cancer, prostate cancer and pan­cre­atic cancer.

Re­act­ing to the re­port by AIHW, Dr He­len Zor­bas, CEO, Cancer Aus­tralia - a na­tional govern­ment agency work­ing to re­duce the im­pact of cancer on all Aus­tralians and pro­vides in­for­ma­tion on the dis­ease, re­search and clin­i­cal tri­als said that the cancer bur­den is pri­mar­ily due to peo­ple dy­ing ear­lier due to cancer.

“Ninety four per cent of the bur­den of cancer is due to dy­ing pre­ma­turely, how­ever it is likely that this will de­crease into the fu­ture, as over­all cancer mor­tal­ity rates are pre­dicted to fall,” Dr Zor­bas said. “Of con­cern, indige­nous Aus­tralians ex­pe­ri­enced 1.7 times the cancer bur­den of non-indige­nous Aus­tralians, and peo­ple in the low­est so­cio-eco­nomic group ex­pe­ri­enced 1.4 times the cancer bur­den of those in the high­est so­cio-eco­nomic group. Lung cancer was re­spon­si­ble for a large pro­por­tion of these dif­fer­ences.

“The re­port also found that al­most one-quar­ter (22%) of the to­tal cancer bur­den can be at­trib­uted to to­bacco use,” said Dr Zor­bas. “The 17 risk fac­tors an­a­lysed in the study ac­counted for 44% of the cancer bur­den. In ad­di­tion to the bur­den at­trib­ut­able to to­bacco use, a fur­ther 7.2% was due to high body mass, 7.0% due to diet and 6.4% due to phys­i­cal in­ac­tiv­ity.”

“The re­port gives us valu­able in­sights across cancer types and into the fu­ture to the year 2020. These in­sights will in­form our ef­forts not only to re­duce cancer mor­tal­ity but also im­prove the qual­ity of life for sur­vivors of cancer,” Dr Zor­bas said.

Pub­lic, Pri­vate Part­ner­ship

Hail­ing the Aus­tralian govern­ment re­sponse to the

Se­nate Com­mit­tee Re­port, Medicines Aus­tralia (MA), which rep­re­sents the dis­cov­ery-driven phar­ma­ceu­ti­cal in­dus­try in Aus­tralia, in last Novem­ber, noted that it is com­mit­ted to work­ing to­gether with the govern­ment to en­sure that ac­cess to new in­no­va­tive medicines re­mains the high­est pri­or­ity.

Medicines Aus­tralia fur­ther noted that it’s en­cour­ag­ing that the govern­ment agrees that im­prov­ing and stream­lin­ing ex­ist­ing reg­u­la­tory and as­sess­ment pro­cesses for new medicines are key strate­gies to en­sure Aus­tralians have even bet­ter ac­cess to break­through medicines.

As the govern­ment notes in their re­sponse, some of the Se­nate in­quiry’s rec­om­men­da­tions are cur­rently be­ing ad­dressed through re­forms of the Ther­a­peu­tic Goods Ad­min­is­tra­tion (TGA).

In par­tic­u­lar, Medicines Aus­tralia looks for­ward to the pas­sage of leg­is­la­tion cur­rently be­fore Par­lia­ment that in­cludes pro­vi­sions for an­other ex­pe­dited path­way called Pro­vi­sional Ap­proval that aims to speed up ac­cess to new medicines.

The govern­ment’s re­sponse also high­lights the im­por­tance of the Strate­gic Agree­ment, signed with Medicines Aus­tralia, to ad­dress some of the rec­om­men­da­tions of the Se­nate in­quiry.

Not only does the Agree­ment pro­vide $1.8 bil­lion in sav­ings on PBS listed medicines that will be used to pay for new treat­ments, the govern­ment has com­mit­ted to re­form that will im­prove and ac­cel­er­ate pro­cesses that lead to a medicine be­ing made avail­able on the PBS.

Medicines Aus­tralia be­lieves that the govern­ment’s com­mit­ment in the Strate­gic Agree­ment will make a real dif­fer­ence to ac­cess to medicines for Aus­tralians.

Medicines Aus­tralia mem­bers dis­cover, de­velop and man­u­fac­ture the lat­est medicines that are made avail­able to those who need them on the Phar­ma­ceu­ti­cal Ben­e­fits Scheme (PBS). They also un­der­take around one thou­sand clin­i­cal tri­als lo­cally that sup­port the de­vel­op­ment of new medicines and pro­vide 34 thou­sand Aus­tralians with early ac­cess to the lat­est treat­ments, in­clud­ing for can­cers.

More funds to boost cancer re­search projects

The Aus­tralian Govern­ment has an­nounced on De­cem­ber 19, 2017 more sup­port for cancer re­search with $8 mil­lion in grants. Through Cancer Aus­tralia, the govern­ment is investing $6.5 mil­lion com­bined with $2.1 mil­lion from Cancer Aus­tralia’s fund­ing part­ners, Cure Cancer Aus­tralia, Na­tional Breast Cancer Foun­da­tion and Cancer Coun­cil NSW. This brings the to­tal fund­ing for the 2017 round of Cancer Aus­tralia’s Pri­or­ity-driven Col­lab­o­ra­tive Cancer Re­search Scheme (PdCCRS) to $8.6 mil­lion.

The 24 suc­cess­ful grant recipients lead projects fo­cus­ing on pre­ven­tion, di­ag­no­sis and treat­ment of a range of cancer types. These in­clude can­cers of the breast, colon, head and neck, kid­ney, liver, lung, ovary, pan­creas and prostate, as well as acute lym­phoblas­tic leukaemia, leukaemia, melanoma and uveal (a part of the eye) melanoma, mul­ti­ple myeloma and sar­coma. There is also a strong fo­cus on de­feat­ing and im­prov­ing the out­comes of child­hood brain can­cers and other can­cers like neu­rob­las­toma, a cancer of the ner­vous sys­tem com­mon in chil­dren.

Sixty per cent of the grant fund­ing will go to projects that fo­cus on rare and less com­mon can­cers and can­cers with low sur­vival rates. The as­sess­ment process for the 2017 PdCCRS grants was done in col­lab­o­ra­tion with the Na­tional Health and Med­i­cal Re­search Coun­cil.

Cancer Aus­tralia’s PdCCRS has pro­vided $124 mil­lion for pri­or­ity-based cancer re­search since its in­cep­tion in 2007. This lat­est round of grant fund­ing com­ple­ments ex­ist­ing pro­grams like the Aus­tralian Brain Cancer Mis­sion which was an­nounced in Oc­to­ber 2017. The Aus­tralian govern­ment an­nounced a $100 mil­lion fund to de­feat brain cancer and pro­vide bet­ter out­comes for peo­ple suf­fer­ing from the ter­ri­ble dis­ease.

Early De­cem­ber the govern­ment has an­nounced a $640 mil­lion in­vest­ment to sup­port Aus­tralia’s world-lead­ing health and med­i­cal re­searchers as they con­tinue their work to find the next ma­jor med­i­cal break­through.

On De­cem­ber 18 2017, the mid-year bud­get up­date con­firmed over half a bil­lion dol­lars ex­tra for the fight against cancer with ad­di­tional fund­ing for new medicines, screen­ing and test­ing.

Medicines Aus­tralia hailed the on­go­ing com­mit­ment of the govern­ment to list medicines rec­om­mended by the Phar­ma­ceu­ti­cal Ben­e­fits Ad­vi­sory Com­mit­tee (PBAC) in a timely man­ner which will ben­e­fit thou­sands of Aus­tralians who need ac­cess to the lat­est de­vel­op­ments in medicine.

If Aus­tralia with its age­ing and grow­ing pop­u­la­tion is to con­tinue to en­joy world-class ac­cess to the lat­est in­no­va­tions in medicines into the fu­ture, Medicines Aus­tralia noted that there needs to be a dis­cus­sion about how to ap­pro­pri­ately in­vest ad­di­tional money into the PBS. Medicines Aus­tralia be­lieves this is a chal­lenge that needs to be ad­dressed by all sides of pol­i­tics to en­sure long-term pre­dictabil­ity and sus­tain­abil­ity of the PBS which is so cher­ished by the Aus­tralian peo­ple.

Source: AIHW Na­tional Hos­pi­tal Mor­bid­ity Data­base.

Notes: 1. Hos­pi­tal­i­sa­tion for which the care type was re­ported as New­born with no qual­i­fied days and records for ‘Hos­pi­tal board­ers’ and ‘Post­hu­mous or­gan pro­cure­ment’ have been ex­cluded from the anal­y­sis. 2. The rates were age-stan­dard­ised to the 2001 Aus­tralian Stan­dard Pop­u­la­tion and are ex­pressed per 10,000 pop­u­la­tion.

Source: AIHW Aus­tralian Cancer Data­base 2013.

Notes: 1. Can­cers coded in the ICD-10 as C00–C97, D45, D46, D47.1 and D47.3–D47.5 with the ex­cep­tion of those C44 codes that in­di­cate a BCC or SCC. 2. The number of new cases are rounded to the near­est whole. There­fore, male and fe­male counts may not equal to­tal per­sons.

3. The age-spe­cific rates are ex­pressed per 100,000.

4. The all ages rates were age-stan­dard­ised to the Aus­tralian Stan­dard Pop­u­la­tion and are ex­pressed per 100,000 pop­u­la­tion.

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