US Pharmaceuticals Mwapadera Amatetezedwa ku Mpikisano
Ndi ochepa omwe angatsutsane ndi mfundo yakuti mankhwala osokoneza bongo ndi okwera mtengo. Ndipotu malinga ndi Centers for Disease Control and Prevention (CDC), munthu amene ali ndi kachilombo ka HIV yemwe amayamba chithandizo cham'mbuyomu adzakumana ndi ndalama zokwana madola 250,000, ndipo ndizo chifukwa cha mapiritsi awo okha. Ndalama sizingadabwe chifukwa chakuti muyezo umodzi mwa umodzi, monga Triumeq , uli ndi mtengo woposa madola 2,600 pamwezi.
Kuphatikizana kwina kuli kwakukulu kuposa izo .
Ngakhale izi, nthawi zambiri simumamva zambiri ponena za kulira kwa anthu pa mtengo wa mankhwalawa. Izi zili choncho chifukwa ambiri amapeza mankhwala awo omwe amaperekedwa chifukwa cha inshuwaransi kapena thandizo linalake la boma komanso zapadera.
Mu mpweya womwewo, ena amadabwa momwe mankhwala opatsirana pogonana angatengere mtengo wamtengo wapatali ku US pamene tikumva kuti matembenuzidwe enieni samapezeka kokha kunja kwa dziko koma amalandira ndalama zochuluka kuposa 2000 peresenti kuposa zomwe tikulipira apa.
Zifukwa zosawerengera za mankhwala omwe ali ndi kachilombo koyambitsa matenda a Edzi ku US nthawi yomweyo ndi zophweka komanso zosokoneza, zokhudzana ndi sayansi, ndale, ndi zabwino, zopindulitsa zakale. Posiyanitsa nkhani zotsutsanazi, tikhoza kumvetsetsa mavuto omwe anthu omwe ali ndi kachilombo ka HIV akukumana nawo komanso makampani ambiri othandizira zaumoyo.
Pamene Kupititsa Sayansi Kulimbitsa Kukula kwa Mankhwala Osokoneza Bongo
Kuyankhula mwachizolowezi, pamene chilolezo cha mankhwala chikutha (kawirikawiri zaka 20 pambuyo pa chilolezocho poyamba), ufulu wokopera mankhwalawo udzatseguka kwa aliyense amene amasankha kupanga mapulogalamu a generic.
Cholinga cha generic ndi kupikisana ndi mtengo wapachiyambi pamtengo, ndi osewera ambiri omwe amachititsa mpikisano waukulu ndipo, mobwerezabwereza, amawononga ndalama.
Nanga bwanji tisanazione izi ndi mankhwala osokoneza bongo? Ndipotu, zovomerezeka za mndandanda wautali wa antiretrovirals zatha kapena zatsala pang'ono kutha, kuphatikizapo mankhwala omwe kale anali "superstar" monga Sustiva (efavirenz) ndi tenofovir (TDF).
Koma mukayang'anila zolembera za Food and Drug Administration (FDA), mawonekedwe achibadwa amangotumizidwa ndikuvomerezedwa kwa ogwira ntchito mankhwala asanu ndi limodzi. Pa izi, gawo limodzi mwa magawo atatu aligwiritsidwa ntchito pochiza HIV ku US (stavudine ndi didanosine), pomwe onse awiri (Abacavir ndi lamivudine) akulephera.
Ndipo mmenemo muli imodzi mwa mavuto omwe akukumana nawo opanga opanga kachilombo ka HIV: Kusintha kosasintha kwa sayansi kungapangitse anthu ena osokoneza bongo kusiya ntchito.
Kufuna Kwambiri Kumachepetsa Mpikisano wa Generic
Mwachitsanzo, taganizirani za Rescriptor (delavirdine) ndi Aptivus (tipranavir), mankhwala awiri omwe ali ndi kachilombo ka HIV omwe anamwalira mu 2013 ndi 2015, motero. Pamene zonsezi zikugwiritsidwabe ntchito pochiza kachirombo ka HIV, zina, mankhwala atsopano (generation integrase inhibitors) apatsidwa udindo wokondedwa. Mankhwala awa, panthawiyi, athandizidwa kuti akhale osiyana.
Zotsatira zake, Rescriptor ndi Aptivus nthawi zambiri zimagwiritsidwa ntchito ngati "kugwa" pamene mankhwala ena amalephera. Izi zokha zimachepetsa zomwe zimapangitsa ogulitsa kudumphira kupanga zopanga zowonjezera pamene palibe chitsimikizo chotsimikizika cha malonda okhutira.
Mofananamo, ngakhale mankhwala monga TDF akadali pakati pa anthu omwe amagwiritsidwa ntchito kwambiri padziko lonse lapansi, njira yabwino yotchedwa tenofovir alafenamide (TAF) -inayambitsidwa mu 2016 monga momwe chivomerezo cha TDF chinakhazikitsidwa.
Zolinga mwinamwake? Osati kwenikweni, anapatsidwa kuti mawonekedwe atsopanowa amapereka zotsatira zochepa zochepa komanso zapamwamba, zomwe zimatanthauza kuti mankhwalawa amakhalabe nthawi yaitali). Pamapeto pake, TAF ndi mankhwala osokoneza bongo omwe amachotsa TDF, makamaka mu mapiritsi atsopano.
Kotero, kodi izo zikutanthauza kuti ife sitidzawona mitundu yowonjezera ya TDF nthawi iliyonse posachedwa? Ambiri amakhulupirira kuti tidzatero. Ngakhalenso pamene akusowa zofuna, TDF generic akadali ndi malo omwe ali ndi kachilombo ka HIV ndipo akhoza kukumbidwa mwamphamvu ndi inshuwalansi ndi ena othandizira kuti azichepetsa ndalama za mankhwala . Ndipo, potsirizira pake, mpikisano wowonjezera kwambiri kumeneko ali pamsika, m'munsi mitengo idzapita.
Izi zakhala zikuchitika ndi Epzicom , yomwe ili ndi njira ziwiri zomwe zili ndi abacavir ndi lamivudine. Ndizigawo ziwiri zonsezi zimalimbikitsidwa pa mankhwala oyamba, ojambula anayi adalumphira pa bandicog generic ndipo atha kupereka ndalama zopitirira 70 peresenti kuchokera pa dzina la chizindikiro.
Omwe Amagwiritsira Ntchito Mankhwala Osokoneza Bongo Akutetezedwa Kuchokera ku Generic Price Pressures
Omwe akupanga mankhwala osokoneza bongo ku US ali ndi mwayi wapadera wokhala ndi mpikisano wochepa wochokera ku makampani omwe angathe kukhala akuwatsamira.
Choyamba, wogula amafuna kupiritsa mapiritsi amodzi apanga mapiritsi apamtima osakongola kwambiri pamtundu wina uliwonse koma mankhwala omwe amatha. N'zosadabwitsa kuti zovomerezeka za mapepala ambiri kuphatikiza zilibe mapeto a moyo wawo, ndipo zina ngati Truvada (TDF plus emtricitabine) ziyenera kuthera mu 2021.
Kotero ngakhale ngati zipangizo zamagulu zilizonse zimapezeka kwa opanga ojambula, wogula nthawi zambiri amasankha dzina la galasi kuphatikizapo piritsi (pokhapokha, ngati inshuwalansi imawaumiriza kuti achite zinazake).
Koma, ngakhale kupitirira pa nkhani ya zofuna za ogula, mpikisano wothamanga ku US kwa nthawi yayitali yakhazikika mu njira ya wopanga mankhwala osagwiritsa ntchito kachilombo ka HIV. Izi zimachitika makamaka kuti boma la US ndilo limodzi logula kwambiri mankhwala ochepetsa kachilombo ka HIV lero.
Pogwiritsa ntchito ndondomeko yothandizira odwala matenda a AIDS (ADAP) , boma la boma likulamulidwa kugula mankhwalawa mwachindunji kuchokera kwa ogulitsa. Mitengo imayendetsedwa kudzera mu Bungwe la Federal 340B la Mankhwala Ogwiritsa Ntchito Mankhwala, lomwe limatulutsa mtengo wamtengo wapatali kwapakati pa 60 mpaka 70 peresenti. Pambuyo pobwezera ziphuphu, mankhwala a dzina la mankhwala nthawi zonse amatha kukhala otchipa kusiyana ndi anzawo.
Chinthu chinanso chomwe chimateteza mankhwala ndi njira imene mankhwala amathandizira. Mosiyana ndi inshuwalansi yaumwini yaumwini, ADAP chisankho chotsata chongogwiritsidwa ntchito kokha ndi malangizo operekedwa ndi Dipatimenti ya Zaumoyo ndi Zamagulu a Anthu , omwe pakali pano amapereka mapiritsi osakaniza onse-mankhwala omwe amatetezedwa ndi mavoti-monga njira yosankhika mu mankhwala oyamba .
Pamapeto pake, si "kusamvana" kutsogolera malangizo awa. Kafukufuku akhala akuwonetsa kuti anthu omwe ali ndi mankhwala a mapiritsi amodzi amakhala ovomerezeka poyerekeza ndi omwe amatenga mapiritsi angapo. Izi zikutanthawuzira kuti zikhale zapamwamba kwambiri zowonjezereka, zomwe zikutanthauza kuti kachilombo kamene sikhoza kufotokoza ndipo simungathe kukhala ndi mankhwala osokoneza bongo.
Zolungama kapena ayi, ndondomekozi sizingathandize koma zopanga zomwe sizinapangidwe, zomwe zimapangitsa kuti zikhale zovuta kwambiri kuti makampani apamwamba azikangana pa chilichonse koma mkhalidwe wovuta.
Pofuna kuteteza malo awo a msika, pafupifupi onse ogulitsa mankhwala adagwirizana kupereka thandizo la ndalama kwa iwo omwe sangakwanitse kugula mankhwala awo, mwina ngati thandizo la ndalama kapena kulimbikitsidwa kwa iwo omwe sali oyenerera inshuwalansi. Ndi opanga opanga opangira omwe amaumirizidwa kuti azigwirizana.
Koma, monga zowonjezera izi, iwo samayesetsa kuthetsa mtengo wapamwamba wa mankhwala ochepetsa kachirombo ka HIV poyerekeza ndi mankhwala omwewo omwe ali kunja kwa US
Mavuto a Kumayiko Akuyesa Kufufuza ndi Kukula Malamulo
Kampani yayikulu yothandizira ma pharma ndi ntchito yadziko lonse yomwe ikuyenda bwino kuposa malire a US. Sikuti amangogwiritsa ntchito makampaniwa pamtima pamisika yamakono kumene matenda, monga kachilombo ka HIV, akufalikira, amawapatsa mwayi wokhala ndi mphamvu zogwiritsa ntchito maluso awo.
Izi ndizochitika makamaka m'mayiko ngati India, omwe malamulo awo amalola kupanga mankhwala omwe ali ndi kachilombo ka HIV mosasamala za chilolezo. Zotsatira zake n'zakuti, India lero ndi njira yowonjezera yowonjezera ma antiretroviral otero ku mayiko omwe akutukuka, mankhwala osokoneza bongo omwe sagwirizana ndi chiyambi koma adagonjetsedwa ndi FDA.
Momwemo, munthu akhoza kugula Atripla ya generic ndalama pafupifupi $ 50 pamsika wogulitsira ku South Africa, pamene akukumana ndi mtengo woposa $ 2,500 pa Walgreens kapena CVS.
Makampani opanga mankhwala akhala akutsindika kuti kusiyana kumeneku ndi chifukwa cha mtengo wochuluka wa kafukufuku ndi chitukuko (R & D), zomwe sizotenga zaka koma zimatha kufika mabiliyoni a madola. Pamwamba pake, ndizolondola kuti zambiri za R & D zoyamba zikuchitika ku US pakati pa malo omwe amapezeka pa biopharma ndi malo ochita kafufuzidwe.
Malinga ndi malamulo omwe ali pamwambawa, apasitasi akutsutsana, mayiko monga India angapindule mosavuta pazipangizo zopanda ndalama chifukwa sakhala olemedwa ndi malonda a R & D. Mankhwala aakulu kwambiri, mosiyana, alibe zoterezi, ndipo, mwachisawawa, ngakhalenso makasitomala awo.
Kunena zoona, mankhwalawa ndi 80 peresenti ya mankhwala osokoneza bongo a US ndipo 40 peresenti ya mankhwala onse omalizidwa amachokera ku mayiko monga India ndi China, malinga ndi FDA. Ndipo, ngakhale kuti madandaulo akuti India akupha mwa kulepheretsa chivomezi, chiwongoladzanja chaka ndi chaka cha makampani ogulitsa mankhwala a Indian chimaimira chabe 2 peresenti ya ndalama zonse padziko lonse zopezera ndalama.
Kuwonjezera pamenepo, mankhwala ambiri a ku America akugwedezeka kwambiri mu mafakitale a India, kuphatikizapo a Mylan a ku Pennsylvania, omwe mu 2007 adagula ambiri omwe ali ndi Matrix Laboratories, yemwe amapanga mankhwala ambiri omwe amachititsa mankhwala omwe amagwiritsa ntchito mankhwalawa. Kugula kunawathandiza Mylan kukhala chomwe chikugulitsidwa lero padziko lapansi.
Mofananamo, GlaxoSmithKline (GSK) yaikulu kwambiri padziko lonse lapansi, idakalipo, omwe amagwira nawo ntchito monga Aspen Pharmacare, mankhwala a South Africa omwe akukhalabe mmodzi mwa anthu opanga mankhwala omwe ali ndi kachilombo ka HIV. Ubalewu, womwe unakhazikitsidwa mu 2009, unalola GSK kuti alole vuto lake la mankhwala a HIV ku Aspen, kuphatikizapo piritsi yowonjezera mphamvu ya mphamvu, Combivir. Izi zinapangitsa GSK kukhala nawo phindu kuchokera ku malonda a mankhwala awo omwe ali ndi kachilombo ka HIV mu Africa pomwe akukhala ndi mtengo wapamwamba wa matikiti omwe amamasuliridwa mofanana, ku America.
Mu 2016, GSK inagulitsa gawo limodzi la magawo 16 pa Aspen Pharmacare kuti lipeze ndalama zokwana $ 1.9 biliyoni. Izi zinagwirizana ndi kutha kwa Combivir chaka chomwecho.
Otsutsawo anali opanda chidwi, omwe ankatsutsa kuti zizolowezi zoterezi ndizosankhana. Kampani imodzi ya ku America monga Mylan ikhoza kutulutsa mankhwala otsika mtengo, omwe amakhala ndi kachilombo koyambitsa matenda a kachilombo koyambitsa matenda a Edzi omwe sangathe kugulitsa ku United States. Pachilumbachi, chimphona chamitundu yonse monga GSK chingathe "kukhala ndi mkate wake ndi kudya nawo" kuteteza ogulitsa ku America kuti apeze zomwe zilidizo zawo za FDA, zomwe zimayambitsa kachilombo ka HIV.
Kodi Ndingatani Ngati Wogulitsa?
Kugulitsa malire kumalire a mankhwala ochotsa mankhwala ochokera ku mayiko ena kupita ku US kumakhalabe nkhani yothetsa makani, koma imodzi yomwe anthu ogulitsa America akupitilira. Canada ndi chitsanzo chabwino kwambiri, kukumbutsa kutsutsidwa kwa anthu omwe amati ma pharmacies otchuka pa intaneti akupindula ndi mankhwala osagwirizana ndi mankhwala osagonjetsedwa ku US.
Zotsutsazo ndi theka-bwino ndi theka-osati. Malingana ndi ndalama zenizeni, ma pharmacy a ku Canada amalembera ndalama zoposa $ 80 miliyoni pa chaka, chiwerengero chomwe sichingawoneke ngati chowopsya poyerekeza ndi $ 425 biliyoni mu malonda omwe amalembedwa ku US mu 2015.
Pakalipano, lamulo lokhudzana ndi kulowetsedwa kwa mankhwala ndi chinthu china chokha komanso chimodzi chomwe chingakhale chosemphana.
Malinga ndi malamulo a FDA, sikuletsedwa kuti anthu azilowetsa mankhwala aliwonse ku US kuti asagwiritse ntchito pokhapokha ngati akutsatira izi:
- Mankhwalawa ndi ogwiritsidwa ntchito pa matenda aakulu omwe palibe mankhwala ku America
- Sipanakhale chitukuko cha malonda kwa mankhwala kwa US ogula.
- Mankhwalawa sakuimira chiopsezo chachikulu cha thanzi kwa wogwiritsa ntchito.
- Munthu amene akulandira mankhwala amavomereza kuti ali ndi ntchito yake, ndipo amapereka mauthenga othandizira okhudza dokotalayo kapena amatsimikizira kuti mankhwalawa ndi opitiliza chithandizo chomwe chinayambika m'dziko lina.
- Munthuyo samangotenga zoposa miyezi itatu yopereka.
Izi zimapangitsa kuti anthu ena asamakhale komweko kapena anthu omwe ali ndi matenda aakulu komanso osatetezeka kuti atenge mankhwala.
Cholinga cha malamulowa ndi chakuti malamulowa adakhazikitsidwa poganiza kuti a FDA, mwawo omwe, "sangathe kuonetsetsa kuti mankhwala osokoneza bongo ndi otetezeka." Chifukwa chakuti ambiri mwa mankhwala omwe ali ndi kachilombo ka HIV omwe amagwiritsidwa ntchito m'mayiko osauka ndi ovomerezedwa ndi FDA sanasunthire bungwe kapena bungwe la US kuti asinthe malamulo amasiku ano.
Kodi izi zikutanthauza kuti ogula ndi kachilombo ka HIV ku US ali ndi chipinda chokwanira pakulera mankhwala ochepetsa kachilombo ka HIV kuchokera kunja? N'zosakayikitsa kuti pali njira zambiri zomwe zingathandize kuti anthu omwe ali ndi matendawa athe kupititsa patsogolo, kuphatikizapo mapulogalamu othandizira ena (CAPS) ndi mapulogalamu othandizira odwala (PAPs) omwe amaperekedwa ndi ogulitsa mankhwala osokoneza bongo.
Ndipo, mwinamwake, ndizovuta kwambiri kwa onse. Ngakhale pamene anthu angathe kupeza mankhwala osokoneza bongo kupyolera mu CAPs ndi PAPs, mankhwalawa amathabe kupindula kwambiri.
Malinga ndi bungwe la AIDS Healthcare Foundation (AHF), mapulogalamu olemekezeka kwambiri sangathe kuonedwa kuti chikondi chimaperekedwa kuti opanga angapangitse kuti phindu la msonkho lipitirire kawiri kawiri poyerekeza ndi mankhwala operekedwa popereka mankhwala okwera mtengo kuti athetse ADAP yonse yomwe ilipo. ndalama. Momwemonso, ma CAPS ndi PAPs sakhala opindulitsa kwa makampani osokoneza bongo koma amapindulitsa kwambiri.
Izi zingasinthe ngati mankhwala ena akuyandikira tsiku lawo lomaliza, zomwe zimapangitsa kuti anthu ambiri azigwira nawo mankhwala osokoneza bongo. Mpaka apo, ogula ambiri a ku America adzayenera kudalira mndandanda wamakono opatsirana-ADAPs, CAPs, PAPs, inshuwalansi-kuchepetsa kulemera kwa mankhwala awo okwera mtengo a HIV.
> Zotsatira:
> Foni yamalonda. "Othandizira Odwala Matenda Achipatala - Makampani Omwe Amawagwiritsa Ntchito Edzi Achipatala 'Mapulogalamu Othandizira' Amalephera Odwala, Koma Amapereka Mamiliyoni Ambiri Amisonkho Amatsitsa Malonda, AHF." Idasindikizidwa pa intaneti pa August 2, 2011.
> Farnham, P .; Gopalappa, C .; Dipo, S .; et al. "Zosintha za Moyo wa Ndalama Zosamaliranso ndi Moyo Womwe Zimayesa Anthu Omwe ali ndi kachilombo ka HIV ku United States: Kutha Posachedwapa ndi Kufufuza Kwambiri ndi Kulowa M'kusamalidwa." Journal of Deficiency Immune Deficiency Syndromes. October 2013: 64: 183-189.
> London Stock Exchange. "GlaxoSmithKline amatha kugulitsa magawo otsala a Aspen." London, England; malemba otsogolera 1740L; September 29, 2016.
> Ma Institutes of Health (NIH). "Malangizo Othandizira Ogwiritsa Ntchito Matenda Ochepetsa Matenda Ochepetsa HIV / 1 Okalamba ndi Achinyamata Odwala - Zowonjezera B: Zida Zogwiritsira Ntchito Mankhwala Matayala (Mwezi Womwe Unapatsidwa Mtengo Wapatali wa Mankhwala Osokoneza Bongo)." Rockville, Maryland; April 2016.
> US Food and Drug Administration (FDA). "Mavitamini ovomerezeka a antiretroviral ogwiritsidwa ntchito pochiza HIV." Silver Spring, Maryland; February 4, 2014.